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Orthopaedic Spreader
EUDAMEDClass IIa (EU MDR)
Ref 03.211.456Model Orthopaedic SpreaderRef 03.401.060Ref 399.100Ref 399.125
by Synthes GmbH
Identity
- Device Name
- Orthopaedic Spreader EUDAMED
- Model / Reference
- Orthopaedic Spreader EUDAMED03.211.456 EUDAMED03.401.060 EUDAMED399.100 EUDAMED399.125 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07611819614802 EUDAMED07611819341494 EUDAMED07611819027558 EUDAMED07611819221055 EUDAMED
- Basic UDI-DI
- 7611819a00464JW EUDAMED
- Direct Marketing DI
- 07611819614802 EUDAMED07611819341494 EUDAMED07611819027558 EUDAMED07611819221055 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
No
EUDAMEDEUDAMED
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
Orthopaedic Spreader by Synthes GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthopaedic guidewire, reusable.
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- Made-To-Order — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
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 | 7611819a00464JW | 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 34bc8749-1f90-46d4-8329-26eaa4bdfe35 61 fields · synced Aug 4, 2026
- EUDAMED c48d281b-6698-464b-b65c-d5c8aa7207a6 61 fields · synced May 17, 2026
- EUDAMED cb26e443-fc75-4f94-9c05-85c739f02419 61 fields · synced May 18, 2026
- EUDAMED d1a6044f-2bc2-4fa5-bd5e-a62631676d9b 61 fields · synced May 19, 2026