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Large handle, cannulated, quick coupling
EUDAMEDClass I (EU MDR)
Ref B-ISC-9013
Identity
- Trade Name
- Large handle, cannulated, quick coupling EUDAMEDActiva Instrument EUDAMED
- Device Name
- Handle EUDAMEDLarge handle, cannulated, quick coupling EUDAMED
- Model / Reference
- B-ISC-9013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438394007154 EUDAMED
- Basic UDI-DI
- 6438394INS011WH EUDAMEDB-06438394007154 EUDAMED
- Direct Marketing DI
- 06438394007154 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
Large handle, cannulated, 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 |
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Manufacturer
- Manufacturer
- Bioretec Ltd.
- EUDAMED SRN
- FI-MF-000001328
Sources (2)
- EUDAMED 2be23cee-20a2-4e16-b224-5c5fff8f2ffb 61 fields · synced Jun 19, 2026
- EUDAMED d45ce5c7-7657-483b-b980-fbee4b73e3de 61 fields · synced May 17, 2026