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Access Kit Drill Biopsy Kit 10G
EUDAMEDClass IIa (EU MDR)
Ref 03.804.521SModel Spine Access Kit 10GRef 03.804.515SRef 03.804.520SRef 03.804.519S
by Synthes GmbH
Identity
- Device Name
- Access Kit Drill Biopsy Kit 10G EUDAMED
- Model / Reference
- Spine Access Kit 10G EUDAMED03.804.521S EUDAMED03.804.515S EUDAMED03.804.520S EUDAMED03.804.519S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07611819540576 EUDAMED07611819540545 EUDAMED07611819543133 EUDAMED07611819540569 EUDAMED
- Basic UDI-DI
- 7611819a00461JQ 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
Access Kit Drill Biopsy Kit 10G 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 | 7611819a00461JQ | 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 (4)
- EUDAMED 8b21e859-e87b-4385-b23e-9861bd37c26a 61 fields · synced Aug 3, 2026
- EUDAMED 03db8a87-e08e-49a4-90ab-ccd12829bbfe 61 fields · synced May 18, 2026
- EUDAMED 27716d7e-88f1-4e4d-bf37-858b44cbd2af 61 fields · synced May 18, 2026
- EUDAMED a8692b4b-fa8c-44a7-8efd-9c5fa74f2677 61 fields · synced May 19, 2026