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Free Triiodothyronine test (Chemiluminescence Immunoassay)
EUDAMEDClass B (EU MDR)
Ref HGCL42Model Please see the IFU
Identity
- Trade Name
- Free Triiodothyronine test (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Free Triiodothyronine test (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- Please see the IFU EUDAMEDHGCL42 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936700403244 EUDAMED
- Basic UDI-DI
- 697029753088LS EUDAMED
- EMDN Code
- W01020401 FREE TRIIODOTHYRONINE EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany 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
New Device
No
EUDAMED
Free Triiodothyronine test (Chemiluminescence Immunoassay) by Beijing Hotgen Biotech Co., Ltd. — Class B — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697029753088LS | Class B | Active |
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Manufacturer
- Manufacturer
- Beijing Hotgen Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000015566
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED ecf3808b-7567-4f9d-9b3d-8e2268fe0ba8 61 fields · synced Jun 18, 2026