Identity
- Trade Name
- Gynaecology & Obstetrics EUDAMED
- Device Name
- GYN (Gynaecology & Obstetrics) EUDAMED
- Model / Reference
- GYN 01 EUDAMEDSYN-GYN01-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05065021834275 EUDAMED
- Basic UDI-DI
- 5065021834SYNPP027ZK EUDAMED
- EMDN Code
- Z12080299 GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I 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 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 | 5065021834SYNPP027ZK | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SYNDEO Medical
- EUDAMED SRN
- BE-PR-000044136
Sources (1)
- EUDAMED df3f1567-15c3-49b2-8ccc-2d074e510372 61 fields · synced Jun 18, 2026