Identity
- Trade Name
- Holding sleeve, for 2.0/2.7/3.5mm screws EUDAMEDActiva Instrument EUDAMED
- Device Name
- Holding Sleeve EUDAMEDHolding sleeve, for 2.0/2.7/3.5mm screws EUDAMED
- Model / Reference
- B-IS-3503 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438394001435 EUDAMED
- Basic UDI-DI
- 6438394INS013WM EUDAMEDB-06438394001435 EUDAMED
- Direct Marketing DI
- 06438394001435 EUDAMED
- EMDN Code
- L098099 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER ACCESSORIES 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
Holding sleeve, for 2.0/2.7/3.5mm screws by Bioretec Ltd. — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 6438394INS013WM | Class I | Active |
| EUDAMED | European Union | CE/MDR | 6438394INS013WM | Class I | Active |
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Manufacturer
- Manufacturer
- Bioretec Ltd.
- EUDAMED SRN
- FI-MF-000001328
Sources (2)
- EUDAMED 4a7218d6-7d7b-48f2-ad35-43fa2ff630fd 61 fields · synced Jul 26, 2026
- EUDAMED 25048c5f-fdff-4901-a5e0-a7417b0078a8 61 fields · synced May 18, 2026