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Special Procedures
EUDAMEDClass IIb (EU MDR)
Ref SYN-SPC03-001Model SPC 03Ref SYN-SPC02-001Model SPC 02
Identity
- Trade Name
- Special Procedures EUDAMED
- Device Name
- SPC (Special Procedures) EUDAMED
- Model / Reference
- SPC 03 EUDAMEDSYN-SPC03-001 EUDAMEDSPC 02 EUDAMEDSYN-SPC02-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05065021834343 EUDAMED05065021834206 EUDAMED
- Basic UDI-DI
- 5065021834SYNPP034ZG EUDAMED5065021834SYNPP020Z5 EUDAMED
- EMDN Code
- V901699 SPECIALIST SURGICAL INSTRUMENTS AND KITS NOT INCLUDED IN OTHER CLASSES, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass IIa EUDAMED
- Medical Purpose
- Tailored for complex or unique surgeries requiring specialized sterile instruments. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Category: General internal orthopaedic fixation system implantation kit
Special Procedures by SYNDEO Medical — Class IIb — MDR — 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5065021834SYNPP034ZG | Class IIb | Active |
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Manufacturer
- Manufacturer
- SYNDEO Medical
- EUDAMED SRN
- BE-PR-000044136
Sources (2)
- EUDAMED 7418360d-29f8-4f7c-9b6d-cf4f2f5fe80f 61 fields · synced Jul 20, 2026
- EUDAMED 9c9322d4-a76a-41bb-a814-1b6ea9f302d9 61 fields · synced May 17, 2026