Identity
- Model / Reference
- TKL-1-60C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04544607401519 EUDAMED
- Basic UDI-DI
- B-04544607401519 EUDAMED
- EMDN Code
- H0399 HAEMOSTASIS CLIPS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Tkl-1-60c by BEAR Medic Corporation — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04544607401519 | Class IIa | Active |
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Manufacturer
- Manufacturer
- BEAR Medic Corporation
- EUDAMED SRN
- JP-MF-000018095
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 07bc44c7-8ba0-4079-8fbe-09cffbd4db96 61 fields · synced Sep 18, 2026