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LH Rapid Quantitative Test (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref BT0503102Ref BT0503105
Identity
- Trade Name
- LH Rapid Quantitative Test (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- LH Rapid Quantitative Test (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- BT0503102 EUDAMEDBT0503105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933260205608 EUDAMED06933260205639 EUDAMED
- Basic UDI-DI
- B-06933260205608 EUDAMEDB-06933260205639 EUDAMED
- EMDN Code
- W0102160304 LH - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
LH Rapid Quantitative Test (Chemiluminescence Immunoassay) by Xiamen Biotime Biotechnology 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-06933260205608 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Xiamen Biotime Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012852
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (4)
- EUDAMED 84081f97-a643-4b99-9515-9ed56c3c9328 61 fields · synced Oct 6, 2026
- EUDAMED 11e5a21e-505d-486e-a093-0e2ee25d1be9 61 fields · synced May 18, 2026
- EUDAMED 4f0764da-4740-4d09-92c5-99e0dce051f0 61 fields · synced Jul 17, 2026
- EUDAMED 0aae98cb-ead9-4364-a50b-5690a16959a3 61 fields · synced Jul 26, 2026