Identity
- Trade Name
- Activa Instrument EUDAMEDApplicator tip, arthroscopic, for 2.0 mm pins EUDAMED
- Device Name
- Applicator tip, arthroscopic, for 2.0 mm pins EUDAMEDApplicator EUDAMED
- Model / Reference
- B-IP-2012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438394002395 EUDAMED
- Basic UDI-DI
- B-06438394002395 EUDAMED6438394INS007WS EUDAMED
- Direct Marketing DI
- 06438394002395 EUDAMED
- EMDN Code
- L091099 OSTEOSYNTHESIS 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
Activa Instrument by Bioretec Ltd. — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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-06438394002395 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06438394002395 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bioretec Ltd.
- EUDAMED SRN
- FI-MF-000001328
Sources (2)
- EUDAMED 7d6ca407-dcc6-4948-a4a3-a131497a342d 61 fields · synced Jul 16, 2026
- EUDAMED b39afd49-3fec-4e9e-a209-971526ec3d00 61 fields · synced May 17, 2026