← Back to catalogue
sST2 Controls
EUDAMEDClass IVD General (EU MDR)
Ref 1040391000Model sST2 Control 1: 1 × 2 mL, sST2 Control 2: 1 × 2 mLRef 1040392000Model sST2 Control Level 1：2×2mL
Identity
- Device Name
- sST2 Controls EUDAMED
- Model / Reference
- sST2 Control 1: 1 × 2 mL, sST2 Control 2: 1 × 2 mL EUDAMED1040391000 EUDAMEDsST2 Control Level 1：2×2mL EUDAMED1040392000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975090500416 EUDAMED06975090501413 EUDAMED
- Basic UDI-DI
- B-06975090500416 EUDAMEDB-06975090501413 EUDAMED
- EMDN Code
- W0102152004 CARDIAC MARKER CONTROLS 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
sST2 Controls by Accucise Diagnostics Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06975090500416 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Accucise Diagnostics Inc.
- EUDAMED SRN
- CN-MF-000045017
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED c20d578b-93e6-4e56-a603-effad53258b4 61 fields · synced Jul 25, 2026
- EUDAMED a53905e2-7bce-4cd0-8558-acd41c870fc1 61 fields · synced May 19, 2026