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Gesichtsmanschette unten ohne Steg EM
EUDAMEDFDA UDIClass I (EU MDR)
Ref 15000022
Identity
- Trade Name
- Gesichtsmanschette unten ohne Steg EM EUDAMEDLower face cuff without link FDA UDI
- Generic Name
- Circulating-fluid localized thermal therapy system pack, single-use FDA UDI
- Device Name
- Manschetten, EM EUDAMEDHilotehrm - Lower face cuff without link FDA UDI
- Model / Reference
- 15000022 EUDAMEDCuff - single patient use FDA UDI
- Description
- Hilotehrm - Lower face cuff without link FDA UDI
Identifiers
- Catalog Number
- 15000012 FDA UDI
- Primary DI / UDI-DI
- 04250387100619 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503871MANEMFP EUDAMED
- FDA Product Code
- ILO FDA UDI
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
- GMDN Term
- Circulating-fluid localized thermal therapy system pack, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5720 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hot/cold therapy pack, reusable
Gesichtsmanschette unten ohne Steg EM by Hilotherm GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42503871MANEMFP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- HILOTHERM GmbH
- EUDAMED SRN
- DE-MF-000006176
Sources (2)
- EUDAMED bcdbfa79-dab0-45d4-86a5-9474acf07937 61 fields · synced Jul 9, 2026
- FDA UDI e9df1622-dfe4-4854-a29b-445134cc9c68 34 fields · synced May 29, 2026