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• Countersink for RemeOs™ Screw COM 2.0/2.5 mm, quick coupling
EUDAMEDClass I (EU MDR)
Ref B-IRC-2504C
Identity
- Trade Name
- • Countersink for RemeOs™ Screw COM 2.0/2.5 mm, quick coupling EUDAMED
- Device Name
- Countersink EUDAMED
- Model / Reference
- B-IRC-2504C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438394013148 EUDAMED
- Basic UDI-DI
- 6438394INS001WE EUDAMED
- Direct Marketing DI
- 06438394013148 EUDAMED
- EMDN Code
- L090999 ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER 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
Category: Bone cutting forceps, reusable
• Countersink for RemeOs™ Screw COM 2.0/2.5 mm, quick coupling by Bioretec Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 6438394INS001WE | Class I | Active |
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Manufacturer
- Manufacturer
- Bioretec Ltd.
- EUDAMED SRN
- FI-MF-000001328
Sources (1)
- EUDAMED 8defd321-93dc-4268-b995-0c8959bb12e4 61 fields · synced Jul 8, 2026