Identity
- Device Name
- Sterile Pin Kaps EUDAMED
- Model / Reference
- 14-1035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00690521014121 EUDAMED
- Basic UDI-DI
- 6905210PKST100W6 EUDAMED
- EMDN Code
- A0380 TUBULAR DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Malta EUDAMED
Clinical & Handling
Sterile
Yes
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
Sterile Pin Kaps by Batrik Medical Manufacturing Inc. — 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 | 6905210PKST100W6 | Class I | Active |
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Manufacturer
- Manufacturer
- Batrik Medical Manufacturing Inc.
- EUDAMED SRN
- CA-MF-000007738
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 62d2f1de-6ef8-4ab1-84a1-ff9e32ffde5b 61 fields · synced Jun 18, 2026