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David
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref RH-FSH-S, RH-FSH-C, RH-FSH-BModel strip, cassette, midstream
Identity
- Trade Name
- DAVID EUDAMED
- Device Name
- One Step FSH Urine Test for Self-testing EUDAMED
- Model / Reference
- strip, cassette, midstream EUDAMEDRH-FSH-S, RH-FSH-C, RH-FSH-B EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-RH-FSHFC EUDAMED
- Basic UDI-DI
- B-RH-FSHFC EUDAMED
- EMDN Code
- W0102160301 FSH - RT & POC EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing 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
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
David by Equinox Biotech Co., Ltd. — Class IVD devices for self-testing — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-RH-FSHFC | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Equinox Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000018901
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 057d82a3-0f7c-46ae-b5e3-0f288ae012e6 61 fields · synced May 29, 2026