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Cuvette-8U
EUDAMEDClass A (EU MDR)
Ref 23-07-0055Model Reaction CuvetteRef 23-07-0055D
Identity
- Trade Name
- Cuvette-8U EUDAMED
- Model / Reference
- Reaction Cuvette EUDAMED23-07-0055 EUDAMED23-07-0055D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04580262020023 EUDAMED04580262020030 EUDAMED
- Basic UDI-DI
- 458026201RCRX EUDAMED
- EMDN Code
- W0503010203 SAMPLES ANALYSES, PLASTIC CUVETTES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
New Device
No
EUDAMED
Cuvette-8U by Biolis Medical Corp. — Class A — 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 | 458026201RCRX | Class A | Active |
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Manufacturer
- Manufacturer
- Biolis Medical Corp.
- EUDAMED SRN
- JP-MF-000025468
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED bdac431f-ff6f-4fae-8966-7705ad4fdd9d 61 fields · synced Jul 14, 2026
- EUDAMED 3a172d05-24d3-4b0d-8338-974bae18dfa5 61 fields · synced May 18, 2026