Patient Shirt
by Feixi Hongwei Medical Devices Co., Ltd China EUDAMED
Ref PS036Model PP Isolation gown; SMS Isolation gown; SMMS Isolation gown; SMMMS Isolation gown; Nonwoven Gown; PE Laminated Isolation gown; Patient gown; Visitor Gown; Scrub Suit; Patient Suit; CPE Gown
EMDN T0205
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697491661ISOG0112T | Date6 May 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Disposable Isolation Gown
- Model / Reference
- PP Isolation gown, SMS Isolation gown, SMMS Isolation gown, SMMMS Isolation gown, Nonwoven Gown, PE Laminated Isolation gown, Patient gown, Visitor Gown, Scrub Suit, Patient Suit, CPE Gown, PS036
- Primary DI / UDI-DI
- 06974916610360
- Basic UDI-DI
- 697491661ISOG0112T
- EMDN Code
- T0205 Non-surgical gowns (excluding personal protective equipment - PPE)
- Device Class
- Class I
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000033411
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Feixi Hongwei Medical Devices Co., Ltd
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Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 6374fc37-e744-4734-9314-5b4897ed760e