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Luteinizing Hormone (LH) Assay Kit (Chemiluminescent Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 50 Tests/KitRef 25 Tests/KitRef 100 Tests/Kit
Identity
- Trade Name
- Luteinizing Hormone (LH) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Device Name
- Luteinizing Hormone (LH) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Model / Reference
- 50 Tests/Kit EUDAMED25 Tests/Kit EUDAMED100 Tests/Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974986815023 EUDAMED06974986815016 EUDAMED06974986815030 EUDAMED
- Basic UDI-DI
- B-06974986815023 EUDAMEDB-06974986815016 EUDAMEDB-06974986815030 EUDAMED
- EMDN Code
- W0102050105 LUTEINISING HORMONE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Luteinizing Hormone (LH) Assay Kit (Chemiluminescent Immunoassay) by Wuhan Life Origin Biotech Joint Stock Co., Ltd. — Class IVD General — IVDD — listed in…
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-06974986815023 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wuhan Life Origin Biotech Joint Stock Co., Ltd.
- EUDAMED SRN
- CN-MF-000027340
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 5f3aec33-2f7f-4d8a-8b2f-cc5d5c447c84 61 fields · synced Oct 6, 2026
- EUDAMED f9819283-f6f3-4432-ba6a-73880ecbc094 61 fields · synced May 16, 2026
- EUDAMED 6013af5a-e4fc-4e32-8ed4-2bcc3180a8d8 61 fields · synced May 17, 2026