← Back to catalogue
Antibodies to Thyroglobulin Detection Kit (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 3013805Model 2×50 Tests/kitRef 3008746Model 1×100 Tests/kit
Identity
- Trade Name
- Antibodies to Thyroglobulin Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Antibodies to Thyroglobulin Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 2×50 Tests/kit EUDAMED3013805 EUDAMED1×100 Tests/kit EUDAMED3008746 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202223921 EUDAMED06925794511836 EUDAMED
- Basic UDI-DI
- B-06942202223921 EUDAMEDB-06925794511836 EUDAMED
- EMDN Code
- W0102100303 THYROGLOBULIN AUTOANTIBODY EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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 Thyroglobulin 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-06942202223921 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 72bcc54c-be73-490a-98ce-e257dd52037e 61 fields · synced Jul 30, 2026
- EUDAMED 5f443619-264a-40df-b852-813e4db835ba 61 fields · synced May 18, 2026