Identity
- Device Name
- 117HKW02 EUDAMED
- Model / Reference
- 117HKW02V01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250527623251 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
117hkw02 by Horizonte Textil 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 | 42505276117-HKW-02PJ | Class I | Active |
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Manufacturer
- Manufacturer
- Horizonte Textil GmbH
- EUDAMED SRN
- DE-MF-000006580
Sources (1)
- EUDAMED 6c3ce97e-38b9-48f2-8131-d7505a616cc2 61 fields · synced Jul 9, 2026