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Follicle Stimulating Hormone FSH Rapid Test Midstream
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref FSH-U35Model Midstream
Identity
- Trade Name
- Follicle Stimulating Hormone FSH Rapid Test Midstream EUDAMED
- Device Name
- Follicle Stimulating Hormone FSH Rapid Tests EUDAMED
- Model / Reference
- Midstream EUDAMEDFSH-U35 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804823177 EUDAMED
- Basic UDI-DI
- B-06952804823177 EUDAMED
- EMDN Code
- W0102050104 FOLLICLE STIMULATING HORMONE EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Follicle Stimulating Hormone FSH Rapid Test Midstream by Assure Tech. (hangzhou) 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-06952804823177 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Assure Tech. (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000002170
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 95429901-e7da-4603-803e-81816980eee1 61 fields · synced Jul 20, 2026