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Insulin-Like Growth Factor Binding Protein-3 Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2031E-75Ref 215620006Model Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 100tests/kitRef S2031E-25Ref 100tests/kitModel Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 100tests/kitRef S2031E-200Ref 50tests/kitModel Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 50tests/kitModel Reagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 100tests/kit
Identity
- Device Name
- Insulin-Like Growth Factor Binding Protein-3 Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2031E-75 EUDAMEDReagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 100tests/kit EUDAMED215620006 EUDAMEDS2031E-25 EUDAMEDReagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 100tests/kit EUDAMED100tests/kit EUDAMEDS2031E-200 EUDAMEDReagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 50tests/kit EUDAMED50tests/kit EUDAMEDReagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 100tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792738706 EUDAMED06972719600977 EUDAMED06955792738683 EUDAMED06972719604876 EUDAMED06955792738737 EUDAMED06972719602513 EUDAMED06972719602506 EUDAMED
- Basic UDI-DI
- B-06955792738706 EUDAMEDB-06972719600977 EUDAMEDB-06955792738683 EUDAMEDB-06972719604876 EUDAMEDB-06955792738737 EUDAMEDB-06972719602513 EUDAMEDB-06972719602506 EUDAMED
- EMDN Code
- W0102060406 INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3 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
Insulin-Like Growth Factor Binding Protein-3 Chemiluminescence Immunoassay Kit 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-06955792738706 | 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 (7)
- EUDAMED 632e63a0-d981-415b-af98-6f36eff7c312 61 fields · synced Jul 25, 2026
- EUDAMED 67a2cb52-425f-46ca-9a6b-f008c48f7ef6 61 fields · synced May 17, 2026
- EUDAMED 67509305-f1e2-49d4-8996-0f7742844903 61 fields · synced May 17, 2026
- EUDAMED 8d05c73d-cb57-4822-9353-f38a49b46ed2 61 fields · synced May 18, 2026
- EUDAMED c94d5800-a6c7-41fc-9376-9c51321358b5 61 fields · synced May 18, 2026
- EUDAMED 49f4f3f2-afa6-4f92-872d-e46bf6142dc2 61 fields · synced May 19, 2026
- EUDAMED 08c25b44-eeb1-4c3b-b5c8-321630aa4c13 61 fields · synced May 19, 2026