← Back to catalogue
Hilotherapie Gerät HTP1 incl. Standardzubehör
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 00100010Model Hilotherapy Device HTP1 Pro
Identity
- Trade Name
- Hilotherapie Gerät HTP1 incl. Standardzubehör EUDAMEDHILOTHERM Homecare FDA UDI
- Generic Name
- Circulating-fluid localized thermal therapy system control unit FDA UDI
- Device Name
- HILOTHERM HTP1 Professionell ; HILOTHERM HTP1 Clinic ; HILOTHERM HTP1 HomeCare EUDAMEDHILOTHERM Homecare - Cooling device FDA UDI
- Model / Reference
- Hilotherapy Device HTP1 Pro EUDAMED00100010 EUDAMEDHTP1 Pro FDA UDI
- Description
- HILOTHERM Homecare - Cooling device FDA UDI
Identifiers
- Catalog Number
- 00100010 FDA UDI
- Primary DI / UDI-DI
- 04250387101647 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503871HTP1ProRX EUDAMED
- FDA Product Code
- ILO FDA UDI
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
- GMDN Term
- Circulating-fluid localized thermal therapy system control unit FDA UDI
Classification
- Device Class
- Class IIa 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Hilotherapie Gerät HTP1 incl. Standardzubehör by Hilotherm GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 42503871HTP1ProRX | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- HILOTHERM GmbH
- EUDAMED SRN
- DE-MF-000006176
Sources (2)
- EUDAMED 3bda0d8e-9ccd-4e26-b324-86a1aa837d88 61 fields · synced Jun 18, 2026
- FDA UDI 8ccf4136-cce5-4796-9d82-2020e5ab3a3c 34 fields · synced May 27, 2026