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Synergy Disc Drivers
EUDAMEDClass I (EU MDR)
Ref 1077-5230Model DriverRef 910-00003Model UDI50016 - DriverRef 910-00016
Identity
- Device Name
- Synergy Disc Drivers EUDAMEDSynergy Disc Driver EUDAMED
- Model / Reference
- Driver EUDAMED1077-5230 EUDAMEDUDI50016 - Driver EUDAMED910-00003 EUDAMED910-00016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- ++M670UDI50003X7 EUDAMED+M6709100000303 EUDAMED+M6709100001607 EUDAMED
- Basic UDI-DI
- B-++M670UDI50003X7 EUDAMED++M670UDI50016XG EUDAMED
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER 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 Drivers by Synergy Spine Solutions Inc. — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-++M670UDI50003X7 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-++M670UDI50003X7 | 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 (3)
- EUDAMED 7c5dcae9-2eae-4369-8894-48d4d1227ea9 61 fields · synced Aug 3, 2026
- EUDAMED ed25da9b-0860-4156-b7f7-1b4c86beb799 61 fields · synced Jul 9, 2026
- EUDAMED ebc16c19-6c57-4e3e-953d-18948a7c9933 61 fields · synced Aug 3, 2026