Identity
- Trade Name
- HER-KIT EUDAMED
- Device Name
- HER-KIT EUDAMED
- Model / Reference
- HER-KIT001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15061090190004 EUDAMED
- Basic UDI-DI
- 506109019HERKIT001YG EUDAMED
- Direct Marketing DI
- 15061090190004 EUDAMED
- EMDN Code
- W05019099 SAMPLES COLLECTION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
Her-Kit by Hertility Health — 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 | 506109019HERKIT001YG | Class A | Active |
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Manufacturer
- Manufacturer
- Hertility Health
- EUDAMED SRN
- UK-MF-000046710
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED c5fba18d-c72a-4679-99aa-0d41cebbe821 61 fields · synced Jun 19, 2026