Identity
- Device Name
- 117HKW02 EUDAMED
- Model / Reference
- 117HKW02V02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250527626870 EUDAMED
- Basic UDI-DI
- 42505276117-HKW-02PJ 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
117hkw02 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-02PJ | Class I | Active |
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Manufacturer
- Manufacturer
- Horizonte Textil GmbH
- EUDAMED SRN
- DE-MF-000006580
Sources (1)
- EUDAMED f9e47a51-9501-4893-8e4c-e864e987a395 61 fields · synced Jun 18, 2026