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SP-10 Male Fertility Rapid Test Cassette
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref OSP-902H
Identity
- Device Name
- SP-10 Male Fertility Rapid Test Cassette EUDAMED
- Model / Reference
- OSP-902H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936983119221 EUDAMED06936983107822 EUDAMED
- Basic UDI-DI
- B-06936983119221 EUDAMEDB-06936983107822 EUDAMED
- EMDN Code
- W0102160399 FERTILITY/PREGNANCY RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Lithuania EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
SP-10 Male Fertility Rapid Test Cassette by Hangzhou Alltest Biotech.Co., Ltd. — Class IVD devices for self-testing — IVDD — listed in EUDAMED
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-06936983119221 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Hangzhou Alltest Biotech.Co., Ltd.
- EUDAMED SRN
- CN-MF-000010710
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 65150735-d83b-45b2-884e-3fa02fe17666 61 fields · synced Oct 6, 2026
- EUDAMED d3f3681b-aa53-43dd-856c-afa351d93f80 61 fields · synced May 17, 2026