Identity
- Trade Name
- GynoPrep® 4,3 ml EUDAMED
- Device Name
- GynoPrep® EUDAMED
- Model / Reference
- 361-100-0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04262458250031 EUDAMED
- Basic UDI-DI
- 426245825GP1G9 EUDAMED
- EMDN Code
- W01030708 STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
GynoPrep® 4, 3 ml by Tharmac GmbH — 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 | 426245825GP1G9 | Class A | Active |
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Manufacturer
- Manufacturer
- Tharmac GmbH
- EUDAMED SRN
- DE-MF-000039165
Sources (1)
- EUDAMED 7606cf92-6071-41c7-9b2e-c69548b8f0cd 61 fields · synced Jun 18, 2026