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Aichek
EUDAMEDClass IVD General (EU MDR)
Ref LH706-AE10Y, LH706-AE10N, LH706-AE20Y, LH706-AE20N
Identity
- Trade Name
- Aichek EUDAMEDLH Luteinizing Hormone (CLIA) EUDAMED
- Device Name
- LH Luteinizing Hormone (CLIA) EUDAMED
- Model / Reference
- LH706-AE10Y, LH706-AE10N, LH706-AE20Y, LH706-AE20N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-LH706-AE47 EUDAMED
- Basic UDI-DI
- B-LH706-AE47 EUDAMED
- EMDN Code
- W0102050105 LUTEINISING HORMONE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
Aichek by Hangzhou Aichek Medical Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-LH706-AE47 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (3)
- EUDAMED 13c95d3a-72b9-4542-af99-aa8f3de3ce8b 61 fields · synced Jul 14, 2026
- EUDAMED 5bee3fd2-b773-4689-9d6c-19ccfe1e8c4d-1 61 fields · synced Jul 14, 2026
- EUDAMED 5bee3fd2-b773-4689-9d6c-19ccfe1e8c4d-2 61 fields · synced Jul 14, 2026