Identity
- Device Name
- K-CLAMP EUDAMED
- Model / Reference
- K-CLAMP 11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800012409523 EUDAMED
- Basic UDI-DI
- 8800012409295V8 EUDAMED
- EMDN Code
- L15901102 DAM POSITIONING INSTRUMENTS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
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
K-Clamp by Shinhung Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8800012409295V8 | Class I | Active |
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Manufacturer
- Manufacturer
- Shinhung Co., Ltd.
- EUDAMED SRN
- KR-MF-000022813
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED ca180716-5d3c-4ff2-bffe-b0b31e6ab73d 61 fields · synced Jun 18, 2026