Identity
- Trade Name
- Cryo Console TEC2800-C EUDAMED
- Device Name
- Cryo Console EUDAMED
- Model / Reference
- TEC2800-C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09309001291020 EUDAMED
- Basic UDI-DI
- 9309001291020WZ EUDAMED
- EMDN Code
- W0202059012 COOLING PARAFFIN PLATES EUDAMED
Classification
- Device Class
- Class A 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Cryo Console TEC2800-C by Amos Scientific Pty., 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 | 9309001291020WZ | Class A | Active |
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Manufacturer
- Manufacturer
- Amos Scientific Pty., Ltd
- EUDAMED SRN
- AU-MF-000036895
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 22d1c865-d595-4c6f-a5af-9de4f5766604 61 fields · synced Jun 18, 2026