Identity
- Trade Name
- T-handle, quick coupling EUDAMEDActiva Instrument EUDAMED
- Device Name
- Handle EUDAMEDT-handle, quick coupling EUDAMED
- Model / Reference
- B-IS-9010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438394001381 EUDAMED
- Basic UDI-DI
- 6438394INS011WH EUDAMEDB-06438394001381 EUDAMED
- Direct Marketing DI
- 06438394001381 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
T-handle, quick coupling 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 | 6438394INS011WH | Class I | Active |
| EUDAMED | European Union | CE/MDR | 6438394INS011WH | 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 82d762a0-a1c9-4a2e-81bb-0cd9f735668c 61 fields · synced Jul 30, 2026
- EUDAMED 3dbb261e-5d64-433f-83f4-a9c518692e37 61 fields · synced May 18, 2026