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Thyroid Stimulating Hormone (TSH) Test Kit (Immunofluorescence)
EUDAMEDClass IVD General (EU MDR)
Ref 52026016Model 25T/kitRef 52027016Model 50T/Kit
Identity
- Trade Name
- Thyroid Stimulating Hormone (TSH) Test Kit (Immunofluorescence) EUDAMED
- Device Name
- Thyroid Stimulating Hormone (TSH) Test Kit (Immunofluorescence) EUDAMED
- Model / Reference
- 25T/kit EUDAMED52026016 EUDAMED50T/Kit EUDAMED52027016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950334804567 EUDAMEDD-FA0003YW EUDAMED
- Basic UDI-DI
- B-06950334804567 EUDAMEDB-FA0003YW EUDAMED
- EMDN Code
- W01020410 THYROID STIMULATING HORMONE 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
Thyroid Stimulating Hormone (TSH) Test Kit (Immunofluorescence) by Genrui Biotech Inc. — Class IVD General — 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-06950334804567 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Genrui Biotech Inc.
- EUDAMED SRN
- CN-MF-000017351
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED f564e06f-59a8-468d-9057-5cc54d834148 61 fields · synced Aug 4, 2026
- EUDAMED f7defafe-05fc-41a4-9ad3-5d9d6d89afc4 61 fields · synced May 17, 2026