Identity
- Trade Name
- RESILION EUDAMED
- Device Name
- K20W EUDAMED
- Model / Reference
- RESILION K20W EUDAMED2022 04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800067900068 EUDAMED
- Basic UDI-DI
- 006790006L9 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I 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: Device sterilization/disinfection container, reusable
Resilion by Hexar Humancare Co., Ltd — 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 | 006790006L9 | Class I | Active |
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Manufacturer
- Manufacturer
- Hexar Humancare Co., Ltd
- EUDAMED SRN
- KR-MF-000018422
- Authorised Representative
- Certification Experts NL-AR-000000235
Sources (1)
- EUDAMED d38517b0-5c86-4319-b96a-760b456abd5f 61 fields · synced Jun 18, 2026