← Back to catalogue
Thyroid Stimulating Hormone (TSH) assay Reagent Kit (CMIA)
EUDAMEDClass IVD General (EU MDR)
Ref C2KB005
Identity
- Trade Name
- Thyroid Stimulating Hormone (TSH) assay Reagent Kit (CMIA) EUDAMED
- Model / Reference
- C2KB005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971792054691 EUDAMED
- Basic UDI-DI
- B-06971792054691 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) assay Reagent Kit (CMIA) by Hangzhou Realy Tech 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-06971792054691 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hangzhou Realy Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000004716
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 0b6de553-488b-4964-ba73-abdc31ea7de5 61 fields · synced Jul 17, 2026