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Gynaecology & Obstetrics
EUDAMEDClass IIa (EU MDR)
Ref SYN-GYN02-001Model GYN 02
Identity
- Trade Name
- Gynaecology & Obstetrics EUDAMED
- Device Name
- GYN (Gynaecology & Obstetrics) EUDAMED
- Model / Reference
- GYN 02 EUDAMEDSYN-GYN02-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05065021834060 EUDAMED
- Basic UDI-DI
- 5065021834SYNPP006ZB EUDAMED
- EMDN Code
- Z12080299 GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Used in gynecological and obstetric procedures, providing sterile instruments for reproductive health. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Gynaecology & Obstetrics by SYNDEO Medical — 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 | 5065021834SYNPP006ZB | Class IIa | Active |
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Manufacturer
- Manufacturer
- SYNDEO Medical
- EUDAMED SRN
- BE-PR-000044136
Sources (1)
- EUDAMED a46895f4-c175-44b2-b089-9740d43e9bd5 61 fields · synced Jul 10, 2026