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Human Chorionic Gonadotropin plus the hCG β-subunit Chemiluminescence Immunoass…
EUDAMEDClass IVD General (EU MDR)
Ref S2027E-200Ref S2027E-50Ref 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/kitRef S2027E-150Model Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle ) 50tests/kitModel Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle ) 50tests/kitModel Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )100tests/kit
Identity
- Device Name
- Human Chorionic Gonadotropin plus the hCG β-subunit Chemiluminescence Immunoassay Kit EUDAMEDHuman Chorionic Gonadotropin plus the hCG β-subunit Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2027E-200 EUDAMEDS2027E-50 EUDAMEDReagents（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 EUDAMEDS2027E-150 EUDAMEDReagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle ) 50tests/kit EUDAMEDReagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle ) 50tests/kit EUDAMEDReagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )100tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792738492 EUDAMED06955792738454 EUDAMED06972719604487 EUDAMED06972719602230 EUDAMED06955792738485 EUDAMED06972719606511 EUDAMED06972719606498 EUDAMED06972719606528 EUDAMED
- Basic UDI-DI
- B-06955792738492 EUDAMEDB-06955792738454 EUDAMEDB-06972719604487 EUDAMEDB-06972719602230 EUDAMEDB-06955792738485 EUDAMEDB-06972719606511 EUDAMEDB-06972719606498 EUDAMEDB-06972719606528 EUDAMED
- EMDN Code
- W0102050206 B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMEDHungary EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
Microbial Substances
Yes
EUDAMEDEUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Human Chorionic Gonadotropin plus the hCG β-subunit Chemiluminescence Immunoass… by Sansure Biotech Inc. — 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-06955792738492 | 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 (8)
- EUDAMED 7d2fc106-1e8c-4fbb-ac6f-6fd2fde30847 61 fields · synced Aug 1, 2026
- EUDAMED d3e011f3-7eff-4246-84cd-bb4ae5fdfe7c 61 fields · synced May 18, 2026
- EUDAMED fff804ad-d323-4c3d-a595-ee0ee709df87 61 fields · synced May 18, 2026
- EUDAMED d1c98fca-526d-4e12-9a46-e1b6adf881f8 61 fields · synced May 18, 2026
- EUDAMED ea5e5681-6d6b-4a09-8fb6-232d0bb4f1f5 61 fields · synced May 18, 2026
- EUDAMED 5722d563-e4b2-4dfd-aa04-eafae61715b7 61 fields · synced Jul 23, 2026
- EUDAMED 36151a06-51c4-4137-8b97-a4b17fc953af 61 fields · synced Jul 29, 2026
- EUDAMED 3e1916d4-55b3-44ab-b3cb-4bd16de788a9 61 fields · synced Aug 1, 2026