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Synergy Disc Pilot Cutter
EUDAMEDClass I (EU MDR)
Ref 1077-4441Model UDI50021 - Pilot Cutter
Identity
- Device Name
- Synergy Disc Pilot Cutter EUDAMED
- Model / Reference
- UDI50021 - Pilot Cutter EUDAMED1077-4441 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M670107744410I EUDAMED
- Basic UDI-DI
- ++M670UDI50021X9 EUDAMED
- EMDN Code
- L090901 BONE CUTTERS, 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 Pilot Cutter 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 | ++M670UDI50021X9 | 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 863b0b87-a169-4d33-b3ea-3b02121e05c5 61 fields · synced Jun 11, 2026