← Back to catalogue
single use hemoclips
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref MD-C-HR-230-13-135-Y
Identity
- Trade Name
- single use hemoclips EUDAMEDSingle Use Hemoclip FDA UDI
- Generic Name
- Gastrointestinal endoscopic clip, short-term FDA UDI
- Device Name
- Single Use Hemoclips EUDAMED
- Model / Reference
- MD-C-HR-230-13-135-Y EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970401813179 EUDAMEDFDA UDI
- Basic UDI-DI
- 697040181HRRotationAV EUDAMED
- 510(k) Number
- K212669 FDA UDI
- FDA Product Code
- PKL FDA UDI
- EMDN Code
- G030202 DIGESTIVE ENDOSCOPY, HAEMOSTASIS CLIPS EUDAMED
- GMDN Term
- Gastrointestinal endoscopic clip, short-term FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4400 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
single use hemoclips by Zhejiang Chuangxiang Medical Technology Co., Ltd. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172762 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K212669 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 697040181HRRotationAV | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zhejiang Chuangxiang Medical Technology Co., LTD.
- EUDAMED SRN
- CN-MF-000012417
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 3db188fc-7ca0-4b6d-8eae-cdb71d2120bd 61 fields · synced Jul 11, 2026
- FDA UDI e7ef3071-4701-4d5e-a698-483d163b2893 33 fields · synced May 30, 2026
- FDA 510(k) K172762 1 fields · synced May 18, 2026