Identity
- Trade Name
- Activa Instrument EUDAMED
- Device Name
- K-Wire Ø1.6 mm, length 260 mm, arthroscopic, for 1.5 mm pins/nails EUDAMED
- Model / Reference
- B-IP-1504 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438394000391 EUDAMED
- Basic UDI-DI
- B-06438394000391 EUDAMED
- EMDN Code
- L090999 ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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 — 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06438394000391 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bioretec Ltd.
- EUDAMED SRN
- FI-MF-000001328
Sources (1)
- EUDAMED 30a57e99-d053-497a-97b0-b2e763c79981 61 fields · synced May 22, 2026