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Countersink for RemeOs™ Screw LAG 3.0/3.5/4.0 mm, quick coupling
EUDAMEDClass I (EU MDR)
Ref B-IRC-4004L
Identity
- Trade Name
- Countersink for RemeOs™ Screw LAG 3.0/3.5/4.0 mm, quick coupling EUDAMED
- Device Name
- Countersink EUDAMED
- Model / Reference
- B-IRC-4004L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438394013131 EUDAMED
- Basic UDI-DI
- 6438394INS001WE EUDAMED
- Direct Marketing DI
- 06438394013131 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
Countersink for RemeOs™ Screw LAG 3.0/3.5/4.0 mm, quick coupling 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 | 6438394INS001WE | Class I | Active |
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Manufacturer
- Manufacturer
- Bioretec Ltd.
- EUDAMED SRN
- FI-MF-000001328
Sources (1)
- EUDAMED bef4d600-5060-41c8-b301-1a174297729c 61 fields · synced Jun 18, 2026