Identity
- Trade Name
- CANros EUDAMED
- Device Name
- CANros EUDAMED
- Model / Reference
- CA-002 EUDAMEDCA-002/20 EUDAMEDCA-002/10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908023154033 EUDAMED08908023154026 EUDAMED
- Basic UDI-DI
- 8908023154CandoreROSMC EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Greece 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
New Device
No
EUDAMED
Category: Nucleic acid extraction/isolation kit IVD
CANros by Candore Bioscience — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 8908023154CandoreROSMC | Class A | Active |
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Manufacturer
- Manufacturer
- Candore Bioscience
- EUDAMED SRN
- IN-MF-000038606
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED a5a94f81-346b-4027-8fdd-a2849a71a5b6 61 fields · synced Jul 13, 2026
- EUDAMED 2f067356-eda0-40a7-a297-7df7d50fe574 61 fields · synced May 19, 2026