← Back to catalogue
Thyroid-stimulating hormone test (Up-converting Phosphor Technology)
EUDAMEDClass B (EU MDR)
Ref HGUPT26Model Please see the IFU
Identity
- Trade Name
- Thyroid-stimulating hormone test (Up-converting Phosphor Technology) EUDAMED
- Device Name
- Thyroid-stimulating hormone test (Up-converting Phosphor Technology) EUDAMED
- Model / Reference
- Please see the IFU EUDAMEDHGUPT26 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936700408751 EUDAMED
- Basic UDI-DI
- 697029753437LV EUDAMED
- EMDN Code
- W01020410 THYROID STIMULATING HORMONE 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
Thyroid-stimulating hormone test (Up-converting Phosphor Technology) 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 | 697029753437LV | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beijing Hotgen Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000015566
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 8d5860f2-3b85-461e-90b8-5acb203c4071 61 fields · synced Aug 1, 2026