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DAVID, Family Care Med+, Z1 Pharma
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref LH-MS1, LH-MS2, LH-LS, RH-sLHModel 20 mIU/mL, 25 mIU/mL, 35 mIU/mL, ≤1 mIU/mL
Identity
- Trade Name
- DAVID, Family Care Med+, Z1 Pharma EUDAMED
- Device Name
- One Step Ovulation Urine Tests for Self-testing EUDAMED
- Model / Reference
- 20 mIU/mL, 25 mIU/mL, 35 mIU/mL, ≤1 mIU/mL EUDAMEDLH-MS1, LH-MS2, LH-LS, RH-sLH EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-RH-LHZA EUDAMED
- Basic UDI-DI
- B-RH-LHZA EUDAMED
- EMDN Code
- W0102160304 LH - 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, Family Care Med+, Z1 Pharma 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-LHZA | 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 (2)
- EUDAMED ed3262de-ce58-49ac-8856-022dc58f868a 61 fields · synced Oct 6, 2026
- EUDAMED ed3262de-ce58-49ac-8856-022dc58f868a-1 61 fields · synced Jun 10, 2026