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Soluble Growth Stimulation Expressed Gene 2 Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref 100tests/kitModel Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 100tests/kitModel Reagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 100tests/kitModel Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 100tests/kitRef 50tests/kitModel Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 50tests/kitModel Reagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 50tests/kit
Identity
- Device Name
- Soluble Growth Stimulation Expressed Gene 2 Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 100tests/kit EUDAMED100tests/kit EUDAMEDReagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 100tests/kit EUDAMEDReagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 100tests/kit EUDAMEDReagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 50tests/kit EUDAMED50tests/kit EUDAMEDReagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 50tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972719601776 EUDAMED06972719601783 EUDAMED06972719605514 EUDAMED06972719601721 EUDAMED06972719601738 EUDAMED
- Basic UDI-DI
- B-06972719601776 EUDAMEDB-06972719601783 EUDAMEDB-06972719605514 EUDAMEDB-06972719601721 EUDAMEDB-06972719601738 EUDAMED
- EMDN Code
- W01021314 ST2 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
Soluble Growth Stimulation Expressed Gene 2 Chemiluminescence Immunoassay Kit by Nanjing RealMind Biotech Co., Ltd. — Class IVD General — IVDD — listed in…
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-06972719601776 | 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 (5)
- EUDAMED 14fa51e9-5390-4bcb-9a91-458ca98cbab7 61 fields · synced Oct 6, 2026
- EUDAMED 13b49395-e269-43c1-9d2d-46d6b5d34677 61 fields · synced May 17, 2026
- EUDAMED 042e991b-637f-4109-94e6-9cba88242e68 61 fields · synced May 17, 2026
- EUDAMED d5dffbb0-ab0f-48f0-80b9-0e7c219e2dcf 61 fields · synced May 18, 2026
- EUDAMED f6dad94f-4077-4619-9f74-3c45246ff2e0 61 fields · synced May 19, 2026