Identity
- Trade Name
- HICO-Variotherm 550 EUDAMED
- Device Name
- Hypo-/ hyperthermia systems EUDAMED
- Model / Reference
- 540021 EUDAMED540001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04042301205803 EUDAMED04042301205797 EUDAMED
- Basic UDI-DI
- 4042301Z1204AAVT EUDAMED
- EMDN Code
- Z12040208 BODY THERMOREGULATION EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb 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
HICO-Variotherm 550 by pfm medical hico GmbH — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 4042301Z1204AAVT | Class IIb | Active |
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Manufacturer
- Manufacturer
- pfm medical hico GmbH
- EUDAMED SRN
- DE-MF-000012921
Sources (2)
- EUDAMED 19e97c68-086b-43ea-92b3-628620c27f86 61 fields · synced Jul 9, 2026
- EUDAMED a0ecf7f4-5183-4206-9630-1edf6e45064b 61 fields · synced May 18, 2026