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Contact
+86 132 4819 8029

Services

Comprehensive Medical Device Testing and Validation Services

Surgical Gown / Isolation Gown Testing

Medical Mask / Glove / Dressing Testing

Electric Wheelchair / Walker / Crutch Testing

Other Medical Device Testing

Electrical Safety Testing

Electromagnetic Compatibility (EMC) Testing

Biocompatibility Testing

Shelf Life Validation

Cleaning / Disinfection / Sterilization Validation

Sterile Medical Device Packaging Validation

Medical Device Simulated Transport Validation
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Case Studies

Globally trusted -5000+Compliant Market Launch for Medical Device Companies

100+
FDA 510(K)Case
200+
EU CE Certification
500+
China NMPA Registration
5000+
Global Clients Served
FDA 510(K) Electric Wheelchair / Mobility Scooter Sector

Market Leadership

Since 2022, of 58 global FDA 510(K) clearances for electric wheelchairs, SUNGO Lab supported36个, Market share up to62.1%.

K252517 K251565 K252502 +33 more
62.1%
Market Share
36
SUNGO Lab-Supported Clearances
58
Global Clearances

FDA 510(K)

Electric Wheelchair K252517
Mobility Scooter K251565
N95Mask 2023年
Full-Process Coaching to Clearance

EU CE Certification

Manual Wheelchair MDR Class I
Surgical Gown EN 13795
Sterile Syringe Class IIa
Notified Body Certification

China NMPA Registration

Electric Wheelchair Class II Registration
Medical Mask Registration Testing
Medical Glove Full-Performance Testing
Rapid Market Approval

One Test · Global Acceptance

SUNGO Lab provides testing reports compliant with FDA, CE, and NMPA requirements - one test meets global registration needs.

USFDA
510(K)Submission
EUCE
MDR/IVDR
ChinaNMPA
Registration Testing
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About Us

Professional medical device testing laboratory and technology platform

SUNGO Brand established in 2006

SUNGO Lab (SGT) A professional laboratory and technical service platform of SUNGO Group, focused on medical device testing. Currently accredited byChina CNAS, CMA及US IASLaboratory accredited - issuing scientific, impartial, and precise reports.

5000+
Clients Served
30%+
China Medical Device
100Trusted by Leading Companies
TOP1
EU/US Registration
Market Share

Qualification Accreditation

CMAQualification Recognition

CMA Accreditation

CNASLaboratory Accreditation

China National Accreditation Service (CNAS)

IASInternational Accreditation

IAS International Accreditation

High-Tech Enterprise

National High-Tech Enterprise Recognition

Contact Us

Professional team at your service

Phone Inquiry

+86 132 4819 8029

Email Inquiry

haixiao.gan@sungoglobal.com

Lab Address

Shanghai Office: 958 Kangqiao East Road, Pudong New Area, Shanghai 201315, China
Hefei Office: Building 7, Unit 03, Wanmao Industrial Park, Pengyi Road, Zipeng Town, Feixi County, Hefei, Anhui 231200, China