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Luteinizing Hormone Detection Kit (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 3013830Model 50Tests/KitRef 3008752Model 100Tests/Kit
Identity
- Trade Name
- Luteinizing Hormone Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Luteinizing Hormone Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 50Tests/Kit EUDAMED3013830 EUDAMED100Tests/Kit EUDAMED3008752 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794520258 EUDAMED06925794511850 EUDAMED
- Basic UDI-DI
- B-06925794520258 EUDAMEDB-06925794511850 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
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMEDEUDAMED
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 Detection Kit (Chemiluminescence Immunoassay) by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED
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-06925794520258 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 0c0e7e58-d439-4b43-a8d1-9017256f6bb2 61 fields · synced Jul 9, 2026
- EUDAMED 1298d41d-5f6c-4df7-a1bb-a899df8eabcb 61 fields · synced May 19, 2026