Suzhou Leapmed Healthcare Corporation
Active in EUDAMEDChinafrom SRN EUDAMED FDA SRN CN-MF-000013964 FEI 3013462478
- Devices
- 193
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
What Suzhou Leapmed Healthcare Corporation makes
The manufacturer produces disposable and reusable biopsy guides, ultrasound biopsy kits, and ultrasound cover kits designed for medical imaging and procedural guidance. These products are intended for use in biopsy procedures, including ultrasound-assisted interventions.
The portfolio includes devices classified as Class I, Class II, and Class IIa under regulatory frameworks. These products are listed in the EU’s EUDAMED registry and the FDA’s 510(k) database, reflecting their regulatory authorisation in those markets. The company is based in China.
Catalogue
Search and filter all 193 devicesShowing 51-100 of 193
Company details
- EUDAMED SRN
- CN-MF-000013964
- FDA FEI number
- 3013462478
- DUNS number
- 544411637
- EUDAMED status
- Active
- EUDAMED registered name
- Suzhou Leapmed Healthcare Corporation
- Registered address
- No. 188, Building 7, Fuchunjiang Road, 215163, Suzhou City, China
- [email protected]
- PRRC contact
- Boyu Tang
EUDAMED certificates
5 certificates5 valid, 0 expiredMDR 5next expiry 6 Jun 2029
Eurofins Product Testing Italy S.r.l. 0477 3 certificates
- EPT 0477.MDR.26/6115 Active
Quality management system EU MDR
- Issued
- 26 Mar 2026
- Expires
- 25 Mar 2031
- EPT 0477.MDR.26/6235 Active
Quality management system EU MDR
- Issued
- 20 Jul 2026
- Expires
- 25 Mar 2031
- EPT 0477.MDR.26/6236 Active
Quality management system EU MDR
- Issued
- 20 Jul 2026
- Expires
- 25 Mar 2031
TÜV Rheinland LGA Products GmbH 0197 2 certificates
- HZ 2175018-1 Active
Quality management system EU MDR
- Issued
- 17 Aug 2026
- Expires
- 6 Jun 2029
- Reason
- Ar srn change
- HZ 2175018-1 Active
Quality management system EU MDR
- Issued
- 7 Jun 2024
- Expires
- 6 Jun 2029