Identity
- Trade Name
- Stand plate complete EUDAMED
- Device Name
- Hypo-/ hyperthermia systems EUDAMED
- Model / Reference
- 542810 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04042301216410 EUDAMED
- Basic UDI-DI
- 4042301Z1204ACVX EUDAMED
- Direct Marketing DI
- 04042301216410 EUDAMED
- EMDN Code
- Z12040208 BODY THERMOREGULATION EQUIPMENT EUDAMED
Classification
- Device Class
- Class I 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
Stand plate complete by pfm medical hico GmbH — Class I — 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 | 4042301Z1204ACVX | Class I | Active |
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Manufacturer
- Manufacturer
- pfm medical hico GmbH
- EUDAMED SRN
- DE-MF-000012921
Sources (1)
- EUDAMED 0e9a398e-0c6e-4e7b-9650-8595ae5a146d 61 fields · synced Jul 17, 2026