Identity
- Device Name
- GynoPrep Selfsampling Set EUDAMED
- Model / Reference
- 360S-1-0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04262458250932 EUDAMED
- Basic UDI-DI
- 426245825GSSSE8 EUDAMED
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER 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
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
Yes
EUDAMED
GynoPrep Selfsampling Set 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 | 426245825GSSSE8 | Class A | Active |
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Manufacturer
- Manufacturer
- Tharmac GmbH
- EUDAMED SRN
- DE-MF-000039165
Sources (1)
- EUDAMED a74951be-61f0-4a2e-9070-e4a77171d418 61 fields · synced Jun 19, 2026