Identity
- Device Name
- Disposable coverall EUDAMED
- Model / Reference
- HXCR-01 EUDAMED2169721 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974181710024 EUDAMED
- Basic UDI-DI
- 697418171HXCR01PV EUDAMED
- EMDN Code
- T0203 DRESSING AND ASSISTANCE KITS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
Disposable coverall by Xianning Huaxin Garment Co., Ltd. — 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 | 697418171HXCR01PV | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xianning Huaxin Garment Co., Ltd
- EUDAMED SRN
- CN-MF-000008984
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 57b5aa57-958b-4623-b8fd-cdbed2ab81c3 61 fields · synced Jun 17, 2026