Identity
- Trade Name
- Activa Instrument EUDAMEDTap Ø2.0 mm, for 2.0 mm screws EUDAMED
- Device Name
- Tap Ø2.0 mm, for 2.0 mm screws EUDAMEDTap EUDAMED
- Model / Reference
- B-IS-2001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438394001336 EUDAMED
- Basic UDI-DI
- B-06438394001336 EUDAMED6438394INS005WN EUDAMED
- Direct Marketing DI
- 06438394001336 EUDAMED
- EMDN Code
- L098003 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY TAPS, REUSABLE 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
Activa Instrument by Bioretec Ltd. — Class IIa — 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-06438394001336 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06438394001336 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bioretec Ltd.
- EUDAMED SRN
- FI-MF-000001328
Sources (2)
- EUDAMED 04a84e41-814e-427b-92c2-f4ba60bd1cfa 61 fields · synced Jul 12, 2026
- EUDAMED 8320c76f-2bd4-4e22-95fa-9bf8c8b58ed9 61 fields · synced May 17, 2026