Identity
- Trade Name
- NON-GYN Solution EUDAMED
- Device Name
- GYN Solution EUDAMED
- Model / Reference
- CORE002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684341089188 EUDAMED
- Basic UDI-DI
- 8684341089COREDQ EUDAMED
- EMDN Code
- V0999 FLUIDS/GASES FOR CLINICAL/THERAPEUTICAL USE - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
NON-GYN Solution by Medikal Olusum Sanayi ve Ticaret Limited Sirketi — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 8684341089COREDQ | Class A | Active |
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Manufacturer
- Manufacturer
- Medikal Olusum Sanayi ve Ticaret Limited Sirketi
- EUDAMED SRN
- TR-MF-000026274
Sources (1)
- EUDAMED e6f81e3c-e78c-4507-aa71-abf0c8864f24 61 fields · synced Jun 18, 2026