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ST2 Assay Reagent Kit (CMIA) PARA DIAGNÓSTICO "IN VITRO"
EUDAMEDClass IVD General (EU MDR)
Ref C2KL004
Identity
- Trade Name
- ST2 Assay Reagent Kit (CMIA) PARA DIAGNÓSTICO "IN VITRO" EUDAMED
- Model / Reference
- C2KL004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976753471975 EUDAMED
- Basic UDI-DI
- B-06976753471975 EUDAMED
- EMDN Code
- W01021314 ST2 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
ST2 Assay Reagent Kit (CMIA) PARA DIAGNÓSTICO "IN VITRO" by Hangzhou Cybereagen Biotech 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-06976753471975 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Cybereagen Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000037850
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 6efcb1a4-998d-4824-9167-06502f73517d 61 fields · synced Oct 7, 2026