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Hilotherm ChemoCare-CIA inkl. Zubehör
EUDAMEDClass IIa (EU MDR)
Ref 20100010Model Hilotherapy Device HT02
Identity
- Trade Name
- Hilotherm ChemoCare-CIA inkl. Zubehör EUDAMED
- Device Name
- Hilotherm ChemoCare-CIPN ; Hilotherm ChemoCare-CIA ; Hilotherm Clinic ; Hilotherm Calido EUDAMED
- Model / Reference
- Hilotherapy Device HT02 EUDAMED20100010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250387104358 EUDAMED
- Basic UDI-DI
- 42503871HT02HA EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Hot/cold therapy pack, reusable
Hilotherm ChemoCare-CIA inkl. Zubehör by Hilotherm GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hot/cold therapy pack, reusable.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42503871HT02HA | Class IIa | Active |
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Manufacturer
- Manufacturer
- HILOTHERM GmbH
- EUDAMED SRN
- DE-MF-000006176
Sources (1)
- EUDAMED 01d45c07-8a78-4422-b377-e596df80d0a1 61 fields · synced Jun 19, 2026