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Luteinizing Hormone Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2039E-25Ref S2039E-100Ref S2039E-150Ref S2039E-50Ref S2039E-200
Identity
- Device Name
- Luteinizing Hormone Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2039E-25 EUDAMEDS2039E-100 EUDAMEDS2039E-150 EUDAMEDS2039E-50 EUDAMEDS2039E-200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792739161 EUDAMED06955792739192 EUDAMED06955792739208 EUDAMED06955792739178 EUDAMED06955792739215 EUDAMED
- Basic UDI-DI
- B-06955792739161 EUDAMEDB-06955792739192 EUDAMEDB-06955792739208 EUDAMEDB-06955792739178 EUDAMEDB-06955792739215 EUDAMED
- EMDN Code
- W0102050105 LUTEINISING HORMONE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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 Chemiluminescence Immunoassay Kit by Sansure Biotech Inc. — 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-06955792739161 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (5)
- EUDAMED a9c16b08-3841-43de-9a60-42fa0e586a2e 61 fields · synced Jul 16, 2026
- EUDAMED f659d76e-5874-4e59-95cf-4572a426bb83 61 fields · synced May 17, 2026
- EUDAMED 1bcba976-1f67-4742-8d5b-e20f58d15879 61 fields · synced May 17, 2026
- EUDAMED 772e06e3-4d83-44ef-9cd0-3f0f21033753 61 fields · synced May 18, 2026
- EUDAMED 505a88d5-1ca5-4f5c-87b2-87f71cf54e1c 61 fields · synced May 18, 2026