Identity
- Trade Name
- Activa Instrument EUDAMEDCountersink, for 4.5mm screws EUDAMED
- Device Name
- Countersink, for 4.5mm screws EUDAMEDCountersink EUDAMED
- Model / Reference
- B-IS-4504 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438394001473 EUDAMED
- Basic UDI-DI
- B-06438394001473 EUDAMED6438394INS001WE EUDAMED
- Direct Marketing DI
- 06438394001473 EUDAMED
- EMDN Code
- L090999 ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass 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
Activa Instrument by Bioretec Ltd. — Class IIa — MDR, MDD — 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
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06438394001473 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06438394001473 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bioretec Ltd.
- EUDAMED SRN
- FI-MF-000001328
Sources (2)
- EUDAMED 88758463-43c2-4fc2-8e8a-d400b7034121 61 fields · synced Jul 11, 2026
- EUDAMED de97551e-84ea-472a-a85b-23e129fe2e04 61 fields · synced May 18, 2026