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ParaTherm Heater / Cooler
EUDAMEDClass IIb (EU MDR)
Ref 54-00-16Model ParaTherm
Identity
- Trade Name
- ParaTherm Heater / Cooler EUDAMED
- Device Name
- ParaTherm 230/220 VAC EUDAMED
- Model / Reference
- ParaTherm EUDAMED54-00-16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060491611098 EUDAMED
- Basic UDI-DI
- B-05060491611098 EUDAMED
- EMDN Code
- Z12019008 BLOOD HEATERS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ParaTherm Heater / Cooler by Chalice Medical Ltd — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05060491611098 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Chalice Medical Ltd
- EUDAMED SRN
- GB-MF-000010617
- Authorised Representative
- Chalice Medical Europe GmbH DE-AR-000007891
Sources (1)
- EUDAMED 496635cc-ce49-4e01-9332-d054720dca1c 61 fields · synced Jul 25, 2026