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DAVID, easy@Home
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref RH-SP10-S, RH-SP10-CModel strip, cassette
Identity
- Trade Name
- DAVID, easy@Home EUDAMED
- Device Name
- Male Fertility Sperm Test for Self-testing EUDAMED
- Model / Reference
- strip, cassette EUDAMEDRH-SP10-S, RH-SP10-C EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-RH-SP10XW EUDAMED
- Basic UDI-DI
- B-RH-SP10XW EUDAMED
- EMDN Code
- W0102160399 FERTILITY/PREGNANCY RT & POC - OTHER 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, easy@Home 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-SP10XW | 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 (3)
- EUDAMED 010d0552-e905-4277-977b-e7c0ba3f0d2e 61 fields · synced Jun 19, 2026
- EUDAMED 010d0552-e905-4277-977b-e7c0ba3f0d2e-1 61 fields · synced Jun 10, 2026
- EUDAMED 010d0552-e905-4277-977b-e7c0ba3f0d2e-2 61 fields · synced Jun 10, 2026