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Quantitative Diagnostic Kit for Neonatal Thyroid Stimulating Hormone (TRFIA)
EUDAMEDClass IVD General (EU MDR)
Ref DR-NS-A001Model 480 tests/kit
Identity
- Device Name
- Quantitative Diagnostic Kit for Neonatal Thyroid Stimulating Hormone (TRFIA) EUDAMED
- Model / Reference
- 480 tests/kit EUDAMEDDR-NS-A001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974671101530 EUDAMED
- Basic UDI-DI
- B-06974671101530 EUDAMED
- EMDN Code
- W01020403 NEONATAL THYROID STIMULATING HORMONE EUDAMED
Classification
- Device Class
- Class IVD General 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
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Quantitative Diagnostic Kit for Neonatal Thyroid Stimulating Hormone (TRFIA) by Darui Biotechnology Co., Ltd. — 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-06974671101530 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Darui Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000030310
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED ca8d34e4-e5b2-4016-8326-22bd287e9419 61 fields · synced Jul 23, 2026