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Synergy Disc Tamps
EUDAMEDFDA PMAClass I (EU MDR)
Ref 1077-5280Model TampRef 910-00011Model UDI50024 - Tamp
Identity
- Device Name
- Synergy Disc Tamps EUDAMED
- Model / Reference
- Tamp EUDAMED1077-5280 EUDAMEDUDI50024 - Tamp EUDAMED910-00011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- ++M670UDI50012X8 EUDAMED+M6709100001102 EUDAMED
- Basic UDI-DI
- B-++M670UDI50012X8 EUDAMED++M670UDI50024XF 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 Tamps by Synergy Spine Solutions Inc. — Class I — MDR, FDA_PMA, MDD — listed in EUDAMED, FDA PMA — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Active
FDA_PMA
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-++M670UDI50012X8 | Class I | Active |
| FDA PMA | United States | FDA_PMA | P250028 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-++M670UDI50012X8 | 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 P250028 61 fields · synced Jul 16, 2026
- EUDAMED 81b3b322-ab69-438f-bd61-d5249b1044de 61 fields · synced Jul 16, 2026
- FDA PMA P250028 1 fields · synced May 21, 2026