Identity
- Trade Name
- Fußmanschette groß EM EUDAMED
- Device Name
- Manschetten, EM EUDAMED
- Model / Reference
- 15000018 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250387100589 EUDAMED
- Basic UDI-DI
- 42503871MANEMFP EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES 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
Fußmanschette groß EM by Hilotherm 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 | 42503871MANEMFP | Class I | Active |
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Manufacturer
- Manufacturer
- HILOTHERM GmbH
- EUDAMED SRN
- DE-MF-000006176
Sources (1)
- EUDAMED 871ace0b-7660-4df9-97b2-fb02feb5ab0e 61 fields · synced Jun 18, 2026