Dr. Astro Inc.  
Solutes to Our Healthcare Workers—  
You are Our HERO MAKING HISTORY!  
It’s an honor to help you.  
I STAYED  
AT WORK  
FOR YOU.  
YOU STAY  
SAFELY  
AT WORK  
FOR US!  
Dr. Astro PPE Mission, Vision & Culture  
Our Mission  
Supply the BEST AVAILABLE PPE  
Our Vision  
We strive to become the largest online & offline PPE platform  
Our Culture  
Love & Collaborations  
Dr. Astro BEST AVAILABLESolutions  
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Why Choose Dr. Astro BEST AVAILABLESolutions  
China & US 24/7 team  
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Sourcing the  
BEST QUALITY  
PPE  
10+ Manufacturer Partners that pass  
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our rigorous Dr. Astro 5-step  
selection criteria  
ENSURE  
Full Compliance  
w/ US FDA  
5
LOCAL  
Customer  
Service &  
Product  
Expert team in areas of  
Chinese company DD  
3
Medical device quality  
US FDA regulatory compliance  
Import/Export  
Support  
BEST  
In the USA  
Shipping  
Solutions  
International shipping solutions  
SMOOTH  
4
Import/Export  
Regulatory  
Customs  
We resolve all the challenges so our  
clients can focus on SAVING LIFES  
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1. Sourcing the BEST QUALITY Respirator, Glove, Isolation Gown  
Dr. Astro 5-Step Due Diligence (DD) Process  
Step 1: Company Information DD (China & US)  
Company history Shareholder and equity structure Credit history  
Legal records Records at NMPA (Chinese FDA) Records at US FDA  
Step 2: In depth DD on the Company  
Industry Reputation Local Reputation  
Product quality history  
Step 3: On-site Inspection (China)  
Our team will visit the manufacturer and inspect the facilities, manufacturing and quality control processes on-site, and talk with the company  
management. We will learn about the company short-term and long-term plan, understand the culture of the company, and make sure the company has  
a long term vision for the business.  
Step 4: Product documentation (China + US)  
We will check all the product documentations including test reports, registration documentations, instructions and labels, packaging, etc, and translate  
all Chinese materials into English,  
Step 5: Product Inspection (Performed in the US). Samples will be sent to our US team for further inspections.  
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2. ENSURE Full Compliance with US FDA  
Our US team, led by BioSculptor President Mark Mazloff, ensure that the products are in full compliance with current FDA requirements.  
Example A: FDA registration of N95 Respirators under EUA  
NMPA approved GB 19083-2010 (Chinese N95): equivalent to the FDA 21 CFR 878.4040(b) (i-iii.) standard N95 respirators  
GB 2626-2006 (KN95): equivalent to the NIOSH N95 standard  
Example B: Surgical gowns  
Sold as Class I medical device in the US  
• NMPA approved YY/T 0506 “Standard Performance” surgical gown: equivalent to the AAMI PB70 Level 2  
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3. BEST Shipping Solutions  
Shipping Method Speed  
Price  
Dr. Astro’s Uniqueness  
We use Fast Boat Direct service that are 40% faster than the  
normal freight ship, while keeping the cost low and maintaining  
a reliable delivery schedule.  
Global Economy  
3 weeks Low  
Products are delivered in batches continuously using a  
combination of air and fast boat. Clients will start receiving  
quickly, while optimally designed combination will keep the  
shipping cost low.  
ASTRO Plan  
1-3  
weeks  
Medium  
We will select the optimal flight route so as to minimize delays  
in transitour plan is typically 30 faster than FEDEX.  
Global Express  
1 week  
High  
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4. SMOOTH Import/Export/Customs/Regulatory Process  
Life without certainty:  
New Government Regulations enacted every weeksometime even changed during the same day  
U.S.A.  
Government Dept.  
US DEPARTMENT OF  
HEALTH AND HUMAN  
SERVICES  
Date  
Effect  
Regulation  
Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against  
COVID-19.  
2020/1/31 public health emergency  
US CDC  
WHO  
2020/2/29 Includes KN95 from China.  
2020/3/11 Pandemic  
Strategies for Optimizing the Supply of N95 Respirators  
COVID-19 declared as Pandemic  
US White House  
US FDA  
US FDA  
2020/3/13 US COVID-19 National Emergency Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak  
2020/3/25 EUA application guidline V1  
2020/3/28 Did not include China  
Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency  
Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators  
US FDA  
US FDA  
2020/4/3 Specifically designed for China.  
2020/4/3 EUA application guidline V2  
Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China  
Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency  
China  
Government Dept.  
Date  
2020/3/15 A large number of products are  
- exported, and the customs does not  
2020/4/10 strictly examine the qualification  
Ensure product quality and safety,  
Effect  
Regulation  
Non-medical only need product certificate. Medical proudcts need CFDA registration certificate and medical device  
production license.  
Customs of PRC  
For five categories of products: the the novel coronavirus reagents, medical masks, medical protective clothing, respirators  
and infrared thermometers, the company MUST provide written statements to customs promising that the export products  
Ministry of Commerce of  
PRC  
Customs head office  
CFDA  
standardize export order, and  
2020/3/31  
prevent export of medical products have obtained the registration certificate of medical devices in China, and in conformity with the quality standards of the  
by non-medical manufacturers.  
To strengthen the supervision of  
2020/4/10 the export quality of medical  
materials  
importing countries (regions).  
Export commodity inspection shall be carried out for medical products under the HS# of "63079000000"  
Customs head office  
Medical use and non-medical use cannot be wrongly claimed or else goods confisticated with severe punishment. Strict  
requirement for packaging specifications and qualification certificates, the inner packing and outer packaging shall be  
regulations for protective products printed with the quality standards of the exporting country and no sticker or sharpies can be used on the label. A lot list of  
Ministry of Commerce of  
PRC  
Customs head office  
CFDA  
2020/4/10  
Special commodity inspection  
-
2020/4/16  
certificate and reports required.  
Administration of market  
supervision, PRC  
Customs head office  
Export of small express parcels have been requested for strictly inspection. Mainly checking whether the labels and  
packages are in compliance with the regulations and whether they are fake. In case of any doubt, the items will be  
withheld. Purchase invoice need to be shown to prove the authenticity of the products.  
2020/4/16 Strictly check the export  
-now qualification of medical supplies  
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4. SMOOTH Import/Export/Customs/Regulatory Process  
Our experienced team will manage the ever-changing environment to ensure a smooth process.  
When there are situations, we will work 24/7 so you don’t have to lose your sleep:  
Our normal hours of work: 7 days/week  
In urgent situations (ie. new regulations released), our team will work around the clock  
We deliver certainty in the uncertain environment:  
1 project manager with direct contact information designated for your order  
Daily update on order statusif delays are expected, we will switch to twice or more updates daily  
24/7 emergency line response  
best response time to changes in government regulations  
We are the best team in navigating through the regulations, and the first to get the PPE (Personal Protective Equipment) to you.  
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5. Local Customer Service & Product Support in the USA  
BioSculptor will provide post-marketing support locally in the US.  
BioSculptor is a Class II medical device manufacturer in Hialeah, FL, with FDA FEI #1000560772. The company was incorporated in  
1972, with medical products sold in the US, EU, and China.  
Client log-in website for detailed product information  
Customer Service & Product Support  
Phone: 305-823-8300  
The designated manager’s mobile phone # will be provided upon PO.  
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Product Order Forms  
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Dr. Astro BEST AVAILABLERespirators  
1 Sourcing the BEST QUALITY Respirators  
2 ENSURE Full Compliance with US FDA  
N95 Equivalent  
KN95 NIOSH Equivalent  
Global Economy  
3 Weeks  
Astro Plan  
Continuous Supply w/ Best Rate  
5-10% of Unit price  
Global Express  
1 Week Air  
3 BEST Shipping Solutions  
~4% of Unit price  
10-20% of Unit price  
4 SMOOTH Import/Export Regulatory Customs Process  
5 Local Customer Service & Product Support in the USA  
China Export & Customs US Import & Customs  
BioSculptor Corporation, Hialeah, FL 33016  
(305) 823-8300.  
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Dr. Astro BEST AVAILABLEGloves  
1 Sourcing the BEST QUALITY Nitrile Gloves  
2 ENSURE Full Compliance with US FDA  
US FDA 510K  
Global Economy Astro Plan  
Global Express  
1 Week Air  
3 BEST Shipping Solutions  
3 Weeks  
Continuous Supply w/ Best Rate  
10-20% of the Unit price  
~1.5% of the Unit price  
~50% of the Unit price  
4 SMOOTH Import/Export Regulatory Customs Process  
5 Local Customer Service & Product Support in the USA  
China Export & Customs US Import & Customs  
BioSculptor Corporation, Hialeah, FL 33016  
(305) 823-8300.  
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Dr. Astro BEST AVAILABLEIsolation Gown  
AAMI Fabric Gown  
1 Sourcing the BEST QUALITY Isolation Gown  
2 ENSURE Full Compliance with US FDA  
AAMI Level 1 equivalent AAMI Level 2 equivalent  
for Civil Use  
Civil Use; Material comply with  
EU Type 3/4/5 surgical gown  
FDA class I Medical Device  
FDA class I Medical Device  
Astro Plan  
Continuous Supply w/ Best Rate  
10-20% of the Unit price  
Global Economy  
3 Weeks  
Global Express  
1 Week Air  
3 BEST Shipping Solutions  
~6% of the Unit price  
~ 110% of the Unit price  
4 SMOOTH Import/Export Regulatory Customs Process  
5 Local Customer Service & Product Support in the USA  
China Export & Customs US Import & Customs  
BioSculptor Corporation, Hialeah, FL 33016  
(305) 823-8300.  
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Dr. Astro Founder  
W. Roy Hua, PhD, Chairman  
Dr. Hua has over 20 years of experience in healthcare sector, focusing on China  
Healthcare and Healthcare investment since 2004. He co-founded “Good Doctor  
Group”, rebuilding the largest physician education group (responsible for over 70% of  
all physician CME in China) into the largest doctor Big Data platform, and built the  
healthcare AI platform for the government and hospitals. Prior to this, he was  
responsible for healthcare industry investment at CITIC PE, one of the largest private  
equity firm in China. He led the acquisition of Biosensors, a multination  
cardiovascular device company and the fourth largest coronary stent company in the  
world. Before CITIC, he was head of Asia Healthcare investment banking at Bank of  
America Merrill Lynch Asia Pacific, responsible for healthcare corporate and investor  
clients in China as well as liaising with US/EU/Japan’s multinational healthcare  
companies. He was Jane Coffin Childs Research Fellow at Yale University School of  
Medicine. Dr. Hua has first-authored discoveries in Nature, Science, and his research  
has been featured on the covers of Journal of Cell Biology and The Scientist. He  
received his BS from University of Science and Technology of China, Masters in  
Physics and PhD in Biophysics and Biochemistry from Brandeis University, and did  
his post-doctoral work at Yale University with Dr. Ira Mellman.  
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Dr. Astro Management  
Amy Hua, GM of Dr. Astro  
VP of Prescription Drug Division and Head of Marketing, Hanwang Pharmaceutical Co., Ltd.  
Head of Business Development, Head of the Shanghai Office, Director of Cardiovascular Division,  
Shaanxi Zhengkang Pharmaceutical Co., Ltd. / Xi'an Libang Pharmaceutical Group  
Master of Marketing & Management, Nanjing University of Economics; Bachelor of Pharmacy,  
Department of Pharmacy, Zhejiang University; BS, Department of Mechanical Engineering,  
Shaanxi University of Technology  
Qin Huang, GM of Dr. Astro eCommerce  
Entrepreneur with a Shenzhen factory, undertaking the electronic chip processing business of foreign-  
invested enterprises and producing various electronic products such as LCD.· After successfully expanding  
the domestic market, expanded the business to Europe, America, Southeast Asia, South Africa and other  
global area markets.  
Marketing department of Shenzhen Saige group (the largest e-market in China) responsible for E-marketing  
and e-commerce business  
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Dr. Astro Management  
Vicky Sun, Vice GM  
20 years of experience in foreign trade, responsible for customer service, product development and design, sales,  
product production, quality control, import and export practice, etc. Successfully served Walmart, Coca Cola, etc.  
Sales & product manager of Hogus Industrial Ltd.  
Director of BTS Trading GmbH China Business Dept.  
GM of HongKong Geelong Group Limited  
Purchasing GM for Lizo Magic GmbH  
Bachelor of Economic Management, Hubei University  
Vigor Huang, Executive Manager  
International trading expert in the world's largest electronic market, with expertise in providing global customers  
with high quality, cost-effective products and logistics solutions, and for building efficient e-commerce platform.  
Sales & Marketing Dept. manager of SZ Xin Guang Dian Electronics Co., Ltd.  
GM of SZ Zhufeng Electronics Co., Ltd.  
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BioSculptor Corporation consist of two main companies, BioSculptor (incorporated  
1994) and Maramed Orthopedic Systems (incorporated 1972).  
Maramed History  
Maramed Orthopedic Systems (previously Maramed Precision Corporation), is a  
commercial thermoforming manufacturing company, specializing in heavy gauge  
thermoplastics and composite materials. We have our own proprietary line of Class I  
(CE marked) medical devices consisting of prefabricated orthoses, fracture braces,  
splints and immobilization devices that are sold all over the world. These products  
are sold both direct and through independent sales reps and distributors. The market  
is all DME providers including hospitals, doctors, therapists and prosthetic/orthotic  
clinics. We provide contract/OEM manufacturing service to other medical device  
companies as well. We offer full engineering services including product development,  
prototyping, tooling and low volume manufacturing of less than 10,000 parts.  
BioSculptor History  
BioSculptor was started as a R&D division of Arthur Finnieston Clinic (est.1928) in  
1987 with the main purpose of developing a CAD/CAM system for the prosthetic and  
orthotic industry. In 1992 we built the first prototype machines and in 1994, we  
incorporated and sold the first BioSculptor CAD/CAM system commercially. Over the  
last 24 years, we have sold our technology all over the world to government/military  
hospitals, educational institutions and commercial clinics. Although the landscape of  
healthcare and technology have changed over that time, we still actively support and  
sell our technologies and capabilities. From this experience, we have become experts  
of taking an analog process, converting it to a digital (computerized) process and  
then ultimately creating a real-world product. These products are usually custom  
products that are manufactured one time only for a specific individual.  
A large part of our business is the manufacturing and supply of the rigid foam blocks  
that are used in the milling/carving machines to create the custom medical devices.  
From this business, we have developed an extensive knowledge of urethane foams,  
both rigid and flexible, and are actively expanding this product line both in product  
offerings, geographic reach and industries.  
BioSculptor also provides custom central fabrication service of products typical in the  
prosthetic/orthotic industry for various clinics around the United States. We also  
manufacture the kinderBAND cranial remolding orthosis which is a custom, class II  
medical device for plagiocephaly and other cranial asymmetries.  
BioSculptor is a registered device manufacturer with the FDA, FEI #1000560772 as a  
contract manufacturer, manufacturer and initial importer. We manufacture both class  
I and II medical device. Our class I medical devices are also CE marked and comply  
to the European Union MDR.  
BioSculptor Corporation 2480 West 82nd Street Hialeah, Florida 33016 305-823-8300   
Dr. Astro Inc.  
+86 400-160-8680  
US Agent/ Representative/Importer  
BioSculptor Corporation  
2480 West 82nd Street, #1  
Hialeah, FL 33016  
305-823-8300