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Case Studies

Global registration success cases - supporting compliant market launch

One Test · One Report · Global Acceptance

100+

FDA 510(K)Case Studies

62.1%

Wheelchair Sector Market Share

200+

EU CE Certification Cases

500+

China NMPA Registration Cases

5000+

Global Clients Served

Leading Position in Electric Wheelchair FDA 510(K)

Since 2022, of 58 global FDA 510(K) clearances for electric wheelchairs, 36 were supported by SUNGO Lab - capturing a market share of62.1%.

End-to-end services from testing to submission - helping companies rapidly obtain FDA clearance and enter the US market.

  • Professional 510(K) Coaching Team
  • Complete Performance Testing Capability
  • Substantial Equivalence Comparison
  • Rapid response to FDA additional information requests
K252517 K251565 K252502 K253001 K250899 K251234 +30 more
62.1%
Market Share
36
SUNGO Lab-Supported Clearances
58
Total Global Clearances

FDA 510(K) Case Studies

US FDA Market Access - Enabling Entry into the US Market

FDA 510(K)

Electric Wheelchair FDA 510(K) Certification

Electric Wheelchair K252517 2024Yearly Clearances

Full-service 510(K) support from testing to submission - including mechanical, electrical safety, and EMC testing - successfully obtaining FDA clearance.

Successfully Obtained FDA 510(K) Clearance
FDA 510(K)

Mobility Scooter FDA Certification

Mobility Scooter K251565 2024Yearly Clearances

Whole-vehicle performance testing, battery safety, and software validation for mobility scooters - supporting successful FDA approval.

Successfully Obtained FDA 510(K) Clearance
FDA 510(K)

N95Mask FDA 510(K) Certification

N95Mask Protective Mask 2023Yearly Clearances

Comprehensive testing including filtration efficiency, breathing resistance, and fit - supporting 510(K) submission preparation and obtaining FDA clearance.

Successfully Obtained FDA 510(K) Clearance

EU Notified Body CE Certification Cases

EU MDR/IVDR Certification - Enabling Market Access in Europe

EU CE Certification

Manual Wheelchair CE-MDR Certification

Manual Wheelchair MDR Class I Notified Body Certification

Complete ISO 7176 testing and technical documentation support - successfully obtaining CE certification.

Successfully Obtained CE-MDR Certificate
EU CE Certification

Surgical Gown CE Certification

Surgical Gown MDR Class I EN 13795

Biocompatibility, barrier performance, and microbial barrier testing - supporting technical documentation and DoC.

Successfully Obtained CE Certificate
EU CE Certification

Sterile Syringe CE Certification

Sterile Syringe MDR Class IIa Notified Body Certification

Physico-chemical, biocompatibility, and sterile barrier system testing - supporting successful Notified Body quality system audit.

Successfully Obtained CE Certificate

China NMPA Registration Success Cases

NMPA Medical Device Registration - Compliant Sales in the China Market

China NMPA Registration

Electric Wheelchair Class II Registration Certificate

Electric Wheelchair Class II Medical Device Registration Testing

GB/T 18029 testing, electrical safety, and EMC registration testing - helping clients obtain Class II medical device registration.

Successfully Obtained NMPA Registration
China NMPA Registration

Medical Surgical Mask Registration Certificate

Medical Surgical Mask Class II Medical Device YY/T 0469

Bacterial/particulate filtration efficiency and synthetic blood penetration testing - enabling rapid registration approval.

Successfully Obtained NMPA Registration
China NMPA Registration

Medical Examination Glove Class I Registration

Medical Glove Class I Medical Device Product Registration

Tensile, puncture resistance, and protein content testing - supporting product registration credentials.

Successfully Obtained Registration Filing

SUNGO Lab vs. Competitors

Why Choose SUNGO Lab? Professional Credentials Meet Industry Experience

SUNGO Lab

  • Triple Accreditation: CNAS + CMA + IAS, One Test, Global Acceptance
  • Globally Recognized Report: ILAC-MRAMember - reports globally100+National Mutual Recognition
  • FDA 510(K)Coaching: 100+Success Stories - 62.1% Market Share in the Wheelchair Sector
  • Dedicated Project Team: Dedicated 1-on-1 service, rapid response, 58-day average cycle
  • End-to-End Service: End-to-end solution from testing to registration
  • Global Registration Coverage: Simultaneously Meets FDA, CE, and NMPA Registration Requirements

Other Labs

  • CMA only - limited international recognition
  • Not an ILAC member - reports not directly usable for international registration
  • Testing only - no registration coaching
  • Standardized process - lacks tailored service
  • Testing only - companies must handle registration themselves
  • Limited standards - difficult to meet multi-country registration needs

One Test · One Report · Global Acceptance

SUNGO Lab holds triple accreditations - CNAS, CMA, and IAS - and is a member of the ILAC-MRA international mutual recognition agreement. One test, one report - accepted for China NMPA registration, US FDA 510(K) submission, and EU CE certification, saving you time and cost.

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CNASAccreditation

China National Accreditation Service (CNAS)

CMACredentials

CMA Accreditation

IASAccreditation

IAS

ILAC-MRA

ILAC Mutual Recognition Arrangement