Identity
- Trade Name
- Tap Ø 4.0 mm, for RemeOs™ Screw 4.0 mm EUDAMED
- Device Name
- Tap EUDAMED
- Model / Reference
- B-IRC-4001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438394013292 EUDAMED
- Basic UDI-DI
- 6438394INS005WN EUDAMED
- Direct Marketing DI
- 06438394013292 EUDAMED
- EMDN Code
- L098003 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY TAPS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Tap Ø 4.0 mm, for RemeOs™ Screw 4.0 mm by Bioretec 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 | 6438394INS005WN | Class I | Active |
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Manufacturer
- Manufacturer
- Bioretec Ltd.
- EUDAMED SRN
- FI-MF-000001328
Sources (1)
- EUDAMED e60adb56-0233-41be-8107-1a7f4c6d4611 61 fields · synced Jul 9, 2026