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Synergy Disc Inserters, Handles, Inserter Components
EUDAMEDClass I (EU MDR)
Ref 1077-5400Model Universal HandleModel UDI50023 - Inserters / Handles / Inserter ComponentsRef 910-00024Ref 1077-5101-002Ref 910-00027-05Ref 910-00015-02Ref 910-00027-06Ref 910-00014Ref 910-00025-002
Identity
- Device Name
- Synergy Disc Inserters, Handles, Inserter Components EUDAMEDSynergy Disc Inserters EUDAMED
- Model / Reference
- Universal Handle EUDAMED1077-5400 EUDAMEDUDI50023 - Inserters / Handles / Inserter Components EUDAMED910-00024 EUDAMED1077-5101-002 EUDAMED910-00027-05 EUDAMED910-00015-02 EUDAMED910-00027-06 EUDAMED910-00014 EUDAMED910-00025-002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- ++M670UDI50011X6 EUDAMED+M670107754000E EUDAMED+M6709100002406 EUDAMED+M670107751010020E EUDAMED+M67091000027050E EUDAMED+M670910000150208 EUDAMED+M67091000027060F EUDAMED+M6709100001405 EUDAMED+M67091000025060D EUDAMED
- Basic UDI-DI
- B-++M670UDI50011X6 EUDAMED++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, Handles, Inserter Components by Synergy Spine Solutions Inc. — Class I — MDR, MDD — 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
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-++M670UDI50011X6 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-++M670UDI50011X6 | 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 (9)
- EUDAMED 38b71e71-b80a-4819-a33f-9f55988562ac 61 fields · synced Aug 4, 2026
- EUDAMED 15306cf5-bd3a-46ad-954c-2ef19145ffce 61 fields · synced Jun 18, 2026
- EUDAMED c84fa83f-951c-4377-a7c9-112160599f97 61 fields · synced Jul 9, 2026
- EUDAMED d68b5ca7-fe23-460d-bff0-f74c1eab86c9 61 fields · synced Jul 10, 2026
- EUDAMED 3dcfc262-9116-4758-a45b-6a5c556c383c 61 fields · synced Jul 13, 2026
- EUDAMED 11022eb1-83dc-453e-98f1-905d6adfe960 61 fields · synced Jul 14, 2026
- EUDAMED b1c051f7-56d1-439f-93f9-0e3045d2e42f 61 fields · synced Jul 14, 2026
- EUDAMED e628f081-ae89-4b56-9feb-8b76d6cb360d 61 fields · synced Jul 26, 2026
- EUDAMED 14c59d68-ed43-43ed-8931-4419db41efc6 61 fields · synced Aug 4, 2026