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Macro Cuvettes with balls
EUDAMEDClass A (EU MDR)
Ref Z05100Model Macro cuvettes with balls
Identity
- Trade Name
- Macro Cuvettes with balls EUDAMED
- Device Name
- Macro cuvettes with balls EUDAMED
- Model / Reference
- Macro cuvettes with balls EUDAMEDZ05100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391521421524 EUDAMED
- Basic UDI-DI
- 53915214CUVETTEUX EUDAMED
- EMDN Code
- W0503010203 SAMPLES ANALYSES, PLASTIC CUVETTES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Macro Cuvettes with balls by Tcoag ireland ltd — 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 | 53915214CUVETTEUX | Class A | Active |
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Manufacturer
- Manufacturer
- Tcoag ireland ltd
- EUDAMED SRN
- IE-MF-000027371
Sources (1)
- EUDAMED 34b8b02c-cc96-4204-ad34-939856838946 61 fields · synced Jun 17, 2026