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Disposable Hemoclip
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref HC-10-195/26P, HC-14-195/26P, HC-10-165/26, HC-10-195/26510(k) K213217
Identity
- Trade Name
- Disposable Hemoclip EUDAMED
- Device Name
- Disposable Hemoclip EUDAMED
- Model / Reference
- HC-10-195/26P, HC-14-195/26P, HC-10-165/26, HC-10-195/26 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-HC7C EUDAMED
- Basic UDI-DI
- B-HC7C EUDAMED
- EMDN Code
- G030202 DIGESTIVE ENDOSCOPY, HAEMOSTASIS CLIPS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Hemoclip by Beijing ZKSK Technology Co., Ltd — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213217 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-HC7C | Class IIa | Active |
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Manufacturer
- Manufacturer
- Beijing ZKSK Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000010403
- FDA Applicant
- Beijing Zksk Technology Co., Ltd.
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (3)
- EUDAMED 945a410b-0745-485b-b9cb-1478390fe087 85 fields · synced Oct 7, 2026
- EUDAMED 945a410b-0745-485b-b9cb-1478390fe087-1 61 fields · synced Jun 10, 2026
- FDA 510(k) K213217 1 fields · synced May 18, 2026