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Spine Biopsy Kit 10G 4.7mm
EUDAMEDClass IIa (EU MDR)
Ref 03.804.613SModel Spine Biopsy Kit
by Synthes GmbH
Identity
- Device Name
- Spine Biopsy Kit 10G 4.7mm EUDAMED
- Model / Reference
- Spine Biopsy Kit EUDAMED03.804.613S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07611819649644 EUDAMED
- Basic UDI-DI
- 7611819a00869KU EUDAMED
- EMDN Code
- Z12139099 VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
Category: Orthopaedic guidewire, reusable
Spine Biopsy Kit 10G 4.7mm by Synthes GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7611819a00869KU | Class IIa | Active |
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Manufacturer
- Manufacturer
- Synthes GmbH
- EUDAMED SRN
- CH-MF-000013345
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (1)
- EUDAMED 976b3d69-9915-4147-9b01-449600d1fee1 61 fields · synced Aug 2, 2026