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Estradiol (E2) rapid test cassette (Rare earth nano fluorescence immunochromato…
EUDAMEDClass IVD General (EU MDR)
Ref IF013
Identity
- Device Name
- Estradiol (E2) rapid test cassette (Rare earth nano fluorescence immunochromatography) EUDAMED
- Model / Reference
- IF013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323014461 EUDAMED
- Basic UDI-DI
- B-06974323014461 EUDAMED
- EMDN Code
- W0102050103 ESTRADIOL EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Estradiol (E2) rapid test cassette (Rare earth nano fluorescence immunochromato… by Beijing Applied Biological Technologies Co., Ltd. — Class IVD General…
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-06974323014461 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Beijing Applied Biological Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000012338
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 6809faa7-7048-4292-967a-da00197bd866 61 fields · synced Jul 23, 2026