Identity
- Device Name
- 117HKW01 EUDAMED
- Model / Reference
- 117HKW01V01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250527623244 EUDAMED
- Basic UDI-DI
- 42505276117-HKW-01PG 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
Category: Hot/cold therapy pack, reusable
117hkw01 by Horizonte Textil GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 42505276117-HKW-01PG | Class I | Active |
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Manufacturer
- Manufacturer
- Horizonte Textil GmbH
- EUDAMED SRN
- DE-MF-000006580
Sources (1)
- EUDAMED 052e5a0f-4631-4f51-b9d3-08b6b8fde86f 61 fields · synced Jun 19, 2026