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Tap Ø4.0 mm, for 4.0 mm cannulated screws
EUDAMEDClass I (EU MDR)
Ref B-ISC-4001
Identity
- Trade Name
- Tap Ø4.0 mm, for 4.0 mm cannulated screws EUDAMEDActiva Instrument EUDAMED
- Device Name
- Tap EUDAMEDTap Ø4.0 mm, for 4.0 mm cannulated screws EUDAMED
- Model / Reference
- B-ISC-4001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438394005181 EUDAMED
- Basic UDI-DI
- 6438394INS005WN EUDAMEDB-06438394005181 EUDAMED
- Direct Marketing DI
- 06438394005181 EUDAMED
- EMDN Code
- L098003 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY TAPS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass 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
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
Tap Ø4.0 mm, for 4.0 mm cannulated screws 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 | 6438394INS005WN | Class I | Active |
| EUDAMED | European Union | CE/MDD | 6438394INS005WN | Class I | Active |
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Manufacturer
- Manufacturer
- Bioretec Ltd.
- EUDAMED SRN
- FI-MF-000001328
Sources (2)
- EUDAMED 0fbc3db7-5448-4cd9-ac1e-eb6b9f3e78f7 61 fields · synced Jul 15, 2026
- EUDAMED 247a4584-a89e-4577-bd7b-70c66001e480 61 fields · synced May 16, 2026