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FSH Rapid Test Cassette
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref FFS-102HRef FFS-R102SQ
Identity
- Trade Name
- FSH Rapid Test Cassette EUDAMED
- Device Name
- FSH Rapid Test Cassette EUDAMED
- Model / Reference
- FFS-102H EUDAMEDFFS-R102SQ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936983106504 EUDAMED06936983188746 EUDAMED
- Basic UDI-DI
- B-06936983106504 EUDAMEDB-06936983188746 EUDAMED
- EMDN Code
- W0102160301 FSH - RT & POC EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Germany EUDAMEDIreland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMEDEUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
FSH Rapid Test Cassette by Hangzhou Alltest 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-06936983106504 | 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 02419e0e-9ea7-4563-917b-f14146cdf1d2 61 fields · synced Jul 9, 2026
- EUDAMED e98c8949-5500-4b87-85ff-ed1218b4fc55 61 fields · synced May 18, 2026