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Dilators
EUDAMEDClass I (EU MDR)
Ref G0884Ref G0885Ref G0352Ref G0350Ref G0887
by Gynemed
Identity
- Trade Name
- Dilators EUDAMED
- Device Name
- FOREIGN BODY MATHIEU FORCEPS, 265MM EUDAMED
- Model / Reference
- G0884 EUDAMEDG0885 EUDAMEDG0352 EUDAMEDG0350 EUDAMEDG0887 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 89640048541874 EUDAMED89640048541942 EUDAMED89640048542482 EUDAMED89640048542246 EUDAMED89640048542000 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 (5)
- EUDAMED e8188673-b312-4c13-82ca-5f6f1d273dbe 61 fields · synced Sep 18, 2026
- EUDAMED 20e8e723-5ae9-4755-89d3-2adc5d9cbacd 61 fields · synced May 17, 2026
- EUDAMED 08cd5246-6d4f-4a23-9d78-d2329a1b8937 61 fields · synced May 17, 2026
- EUDAMED 4f941ada-3d88-4772-8482-aa605a104e62 61 fields · synced May 18, 2026
- EUDAMED 8b12d3c7-ee9f-47bf-9d26-28e95295389b 61 fields · synced May 18, 2026