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ST2 Calibrators
EUDAMEDClass C (EU MDR)
Ref 105-038096-00Model 105-038094-00, 105-038095-00, 105-038096-00, 105-040606-00, 105-040605-00, 105-040608-00, 105-040607-00
Identity
- Trade Name
- ST2 Calibrators EUDAMED
- Device Name
- growth STimulation expressed gene 2 （CLIA）, ST2 Calibrators, ST2 Control EUDAMED
- Model / Reference
- 105-038094-00, 105-038095-00, 105-038096-00, 105-040606-00, 105-040605-00, 105-040608-00, 105-040607-00 EUDAMED105-038096-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06903053045971 EUDAMED
- Basic UDI-DI
- 69449040AB74000515M EUDAMED
- EMDN Code
- W0102152204 CARDIAC MARKER STANDARDS AND CALIBRATORS EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
New Device
Yes
EUDAMED
ST2 Calibrators by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69449040AB74000515M | Class C | Active |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000014156
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED f1b2ef1a-0df8-46f5-894c-087e5016c0f8 61 fields · synced Jun 18, 2026