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Antibodies to Thyroid Peroxidase Detection Kit (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 3008749Model 1×100 Tests/kitRef 3013907Model 1×50 Tests/kitRef 3013806Model 2×50 Tests/kit
Identity
- Trade Name
- Antibodies to Thyroid Peroxidase Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Antibodies to Thyroid Peroxidase Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 1×100 Tests/kit EUDAMED3008749 EUDAMED1×50 Tests/kit EUDAMED3013907 EUDAMED2×50 Tests/kit EUDAMED3013806 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794511843 EUDAMED06925794520234 EUDAMED06942202223938 EUDAMED
- Basic UDI-DI
- B-06925794511843 EUDAMEDB-06925794520234 EUDAMEDB-06942202223938 EUDAMED
- EMDN Code
- W0102100301 THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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
Antibodies to Thyroid Peroxidase Detection Kit (Chemiluminescence Immunoassay) by Dirui Industrial 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-06925794511843 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 66f63e32-c6c0-490b-8491-20f1ebd047d7 61 fields · synced Jul 31, 2026
- EUDAMED 4c69f9ae-b49e-44f1-b4f6-a630c1faaca1 61 fields · synced May 17, 2026
- EUDAMED dbcc6cc5-35b0-4f26-891b-77bbf2d3dab7 61 fields · synced May 19, 2026