Identity
- Device Name
- K-CLAMP EUDAMED
- Model / Reference
- K-CLAMP 44 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800012409592 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
The K-CLAMP medical device is a Class I implantable device designed for the closure of patent ductus arteriosus in infants. It features a simple and effective mechanism, making it an ideal treatment option for this condition. The device has undergone rigorous testing and has received clearance from regulatory bodies around the world.
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 99aee338-1243-4055-bfcd-03205e43def8 61 fields · synced Jul 10, 2026