Identity
- Trade Name
- Dilators EUDAMED
- Device Name
- FOREIGN BODY MATHIEU FORCEPS, 265MM EUDAMED
- Model / Reference
- G0888 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 89640048542178 EUDAMED
- Basic UDI-DI
- 8964004854gynecologyJ3 EUDAMED
- EMDN Code
- L0509020101 VAGINAL DILATORS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Dilators by Gynemed — 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 | 8964004854gynecologyJ3 | Class I | Active |
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Manufacturer
- Manufacturer
- Gynemed
- EUDAMED SRN
- PK-MF-000042135
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED 2996017b-280c-4045-bce4-2e655e0f85f3 61 fields · synced May 23, 2026