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ST2 Growth Stimulation Expressed gene 2 (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref ST2706-AE10Y, ST2706-AE10N, ST2706-AE20Y, ST2706-AE20N
Identity
- Trade Name
- ST2 Growth Stimulation Expressed gene 2 (CLIA) EUDAMED
- Device Name
- ST2 Growth Stimulation Expressed gene 2 (CLIA) EUDAMED
- Model / Reference
- ST2706-AE10Y, ST2706-AE10N, ST2706-AE20Y, ST2706-AE20N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-ST2706-AEXK EUDAMED
- Basic UDI-DI
- B-ST2706-AEXK EUDAMED
- EMDN Code
- W01021314 ST2 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
This device, ST2 Growth Stimulation Expressed gene 2 (CLIA), is a medical device designed to stimulate growth and development in tissues. It utilizes an expressed gene to promote cellular activity, leading to improved tissue regeneration and repair. With its unique features and applications, this device is ideal for various medical specialties, including orthopedic and dermatological procedures.
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-ST2706-AEXK | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED 6c1bd5c4-3e4f-49b2-a749-0401029994bc 61 fields · synced Jul 25, 2026
- EUDAMED 6c1bd5c4-3e4f-49b2-a749-0401029994bc-1 61 fields · synced Jun 10, 2026