Lab1 Shanghai SUNGO Lab Lab2 Lab3 Lab4 Hefei SUNGO Lab HefeiCMA HefeiCNAS HefeiIAS
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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

FDA 510(K) Submission Support

Since 2022, of 58 global FDA 510(K) clearances for electric wheelchairs, SUNGO Lab supported36.

K252517 K251565 K252502 +33 more
36
Cleared K-Numbers
36
SUNGO Lab-Supported Clearances
58
Global Clearances

FDA 510(K)

Electric Wheelchair K252517
Mobility Scooter K251565
N95Mask 2023
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 by CNAS and CMA in China and IAS in the United States, issuing scientific, impartial and precise reports.

5000+
Clients Served
30%+
China Medical Device
100Trusted by Leading Companies
2
Labs in
Shanghai & Hefei

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