Identity
- Trade Name
- Disposable PP coverall EUDAMED
- Device Name
- Disposable PP coverall EUDAMED
- Model / Reference
- HXCR-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16974181710045 EUDAMED
- Basic UDI-DI
- 697418171HXCR01PV EUDAMED
- Direct Marketing DI
- 16974181710045 EUDAMED
- EMDN Code
- T020499 SURGICAL GOWNS - OTHER 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
Yes
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 PP 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 |
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Manufacturer
- Manufacturer
- Xianning Huaxin Garment Co., Ltd
- EUDAMED SRN
- CN-MF-000008984
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 8062f9e2-54eb-4c8c-a751-47f63f86b949 61 fields · synced Jun 18, 2026