Identity
- Trade Name
- Countersink, for 2.0 mm screws EUDAMEDActiva Instrument EUDAMED
- Device Name
- Countersink EUDAMEDCountersink, for 2.0 mm screws EUDAMED
- Model / Reference
- B-IS-2004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438394001459 EUDAMED
- Basic UDI-DI
- 6438394INS001WE EUDAMEDB-06438394001459 EUDAMED
- Direct Marketing DI
- 06438394001459 EUDAMED
- EMDN Code
- L090999 ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa 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 2.0 mm screws by Bioretec Ltd. — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 6438394INS001WE | Class I | Active |
| EUDAMED | European Union | CE/MDR | 6438394INS001WE | Class I | Active |
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Manufacturer
- Manufacturer
- Bioretec Ltd.
- EUDAMED SRN
- FI-MF-000001328
Sources (2)
- EUDAMED 9df41f2f-8a47-4466-be0b-734bd234dcbb 61 fields · synced Jul 12, 2026
- EUDAMED a057be28-e801-4153-a7bb-79cbfb845230 61 fields · synced May 18, 2026