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Synergy Disc Inserters
EUDAMEDClass I (EU MDR)
Ref 910-00008-01Model UDI50023 - Inserters / Handles / Inserter Components
Identity
- Device Name
- Synergy Disc Inserters EUDAMED
- Model / Reference
- UDI50023 - Inserters / Handles / Inserter Components EUDAMED910-00008-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M670910000080109 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
Synergy Disc Inserters by Synergy Spine Solutions Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 eb1c66b7-8340-49c8-a495-474a3287952e 61 fields · synced Jun 19, 2026