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Luteinizing Hormone test (Chemiluminescence Immunoassay)
EUDAMEDClass B (EU MDR)
Ref HGCL16Model Please see the IFU
Identity
- Trade Name
- Luteinizing Hormone test (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Luteinizing Hormone test (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- Please see the IFU EUDAMEDHGCL16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936700403190 EUDAMED
- Basic UDI-DI
- 697029753299M9 EUDAMED
- EMDN Code
- W0102050105 LUTEINISING 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
Luteinizing Hormone test (Chemiluminescence Immunoassay) by Beijing Hotgen Biotech Co., Ltd. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697029753299M9 | 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 d86ce0c9-2454-46e3-a8de-f9051091a0de 61 fields · synced Jul 17, 2026