Identity
- Trade Name
- CARDIAC CONTROL - LEVEL 2 (CRD CONTROL 2) EUDAMED
- Device Name
- CARDIAC CONTROL EUDAMED
- Model / Reference
- CQ10455 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055273217131 EUDAMED
- Basic UDI-DI
- 50552732BCRDCON001AS EUDAMED
- EMDN Code
- W0102152004 CARDIAC MARKER CONTROLS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
No
EUDAMED
Cardiac Control - Level 2 (crd Control 2) by Randox Laboratories Limited — Class B — 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 | 50552732BCRDCON001AS | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Randox Laboratories Limited
- EUDAMED SRN
- XI-MF-000028410
Sources (1)
- EUDAMED 8575d432-bfd8-4529-b1fa-f08b27434a53 61 fields · synced Jul 26, 2026