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Acis
EUDAMEDClass IIa (EU MDR)
Ref 03.841.409Model Spine Trial Implants for ACIS
by Synthes GmbH
Identity
- Trade Name
- ACIS EUDAMED
- Device Name
- ACIS Trial Implant Small Standard Large Convex Parallel Lordotic EUDAMED
- Model / Reference
- Spine Trial Implants for ACIS EUDAMED03.841.409 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07611819473515 EUDAMED
- Basic UDI-DI
- 7611819a00516JQ EUDAMED
- Direct Marketing DI
- 07611819473515 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
No
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
Acis 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 | 7611819a00516JQ | 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 089a1be8-a36e-4778-b895-d9ed8eed8217 61 fields · synced Jun 18, 2026