Identity
- Trade Name
- Activa Instrument EUDAMEDApplicator Ø3.2 mm, reusable, for 3.2 mm pins and for 1.5/2.0/2.7/3.2 mm nails EUDAMED
- Device Name
- Applicator Ø3.2 mm, reusable, for 3.2 mm pins and for 1.5/2.0/2.7/3.2 mm nails EUDAMEDApplicator EUDAMED
- Model / Reference
- B-IP-3200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438394000254 EUDAMED
- Basic UDI-DI
- B-06438394000254 EUDAMED6438394INS007WS EUDAMED
- Direct Marketing DI
- 06438394000254 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-06438394000254 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06438394000254 | Class I | Active |
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Manufacturer
- Manufacturer
- Bioretec Ltd.
- EUDAMED SRN
- FI-MF-000001328
Sources (2)
- EUDAMED f6402606-a153-4614-b0e4-b98809624e1b 61 fields · synced Jul 29, 2026
- EUDAMED b6d85fdf-3983-4975-934b-40347f82fd63 61 fields · synced May 18, 2026