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Luteinizing Hormone Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref 50tests/kitModel Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )50tests/kitRef 100tests/kitModel Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )100tests/kitModel Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )50tests/kitModel Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )100tests/kit
Identity
- Device Name
- Luteinizing Hormone Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )50tests/kit EUDAMED50tests/kit EUDAMEDReagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )100tests/kit EUDAMED100tests/kit EUDAMEDReagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )50tests/kit EUDAMEDReagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )100tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972719604470 EUDAMED06972719602186 EUDAMED06972719602193 EUDAMED06972719604463 EUDAMED
- Basic UDI-DI
- B-06972719604470 EUDAMEDB-06972719602186 EUDAMEDB-06972719602193 EUDAMEDB-06972719604463 EUDAMED
- EMDN Code
- W0102050105 LUTEINISING HORMONE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Hungary 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Luteinizing Hormone Chemiluminescence Immunoassay Kit by Nanjing RealMind Biotech 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-06972719604470 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Nanjing RealMind Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000024838
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (4)
- EUDAMED 211bc92a-9fb8-4404-ba0a-55368dabfe6c 61 fields · synced Oct 7, 2026
- EUDAMED 4463cdf9-f99f-4ceb-8f50-ac96931ffc59 61 fields · synced May 17, 2026
- EUDAMED 8e2b849b-172b-4c2f-86bf-af8df3c25626 61 fields · synced May 17, 2026
- EUDAMED 514146c1-9144-4ea1-97ea-33aefda29c9b 61 fields · synced May 19, 2026