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Synergy Disc Trials
EUDAMEDClass IIa (EU MDR)
Ref 1077-4471-013Model UDI50020 - Trial Sizer
Identity
- Device Name
- Synergy Disc Trials EUDAMED
- Model / Reference
- UDI50020 - Trial Sizer EUDAMED1077-4471-013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M670107744710130P EUDAMED
- Basic UDI-DI
- ++M670UDI50020X7 EUDAMED
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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 Trials by Synergy Spine Solutions Inc. — Class IIa — 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 | ++M670UDI50020X7 | Class IIa | 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 913a995e-b30f-4b82-9d29-ac1c76ad8860 61 fields · synced Jul 14, 2026