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Arch
EUDAMEDClass IIb (EU MDR)
Ref 443.176SModel ARCH Laminoplasty Plate
by Synthes GmbH
Identity
- Trade Name
- ARCH EUDAMED
- Device Name
- Adaption Plate Mini Plate single bend double bend EUDAMED
- Model / Reference
- ARCH Laminoplasty Plate EUDAMED443.176S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07611819865549 EUDAMED
- Basic UDI-DI
- 7611819a00005HS EUDAMED
- EMDN Code
- P09070301 CERVICAL FIXATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
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
Category: Cervical spine immobilization system, single-use
Arch by Synthes GmbH — Class IIb — 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 | 7611819a00005HS | Class IIb | 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 0ddff0e2-1e3a-45f9-8efe-a45d8816626d 61 fields · synced Jun 19, 2026