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Synergy Disc Inserters
EUDAMEDClass I (EU MDR)
Ref 910-00008-02Model UDI50023 - Inserters / Handles / Inserter Components
Identity
- Device Name
- Synergy Disc Inserters EUDAMED
- Model / Reference
- UDI50023 - Inserters / Handles / Inserter Components EUDAMED910-00008-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M67091000008020A EUDAMED
- Basic UDI-DI
- ++M670UDI50023XD EUDAMED
- EMDN Code
- L091104 ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
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: Orthopaedic implant impactor, reusable
Synergy Disc Inserters by Synergy Spine Solutions Inc. — Class I — 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 | ++M670UDI50023XD | Class I | Active |
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Manufacturer
- Manufacturer
- Synergy Spine Solutions Inc.
- EUDAMED SRN
- US-MF-000014165
- Authorised Representative
- MedNet EC-REP III GmbH DE-AR-000011191
Sources (1)
- EUDAMED c1fb9ace-1adf-4ce4-abd7-aa801996cbcc 61 fields · synced Jun 19, 2026