Guohong
by Anhui Guohong Industrial and Trading Co., Ltd 31 variants
Ref XY055-XXL, 20210118-BL/M1, 80170, 20210112-C/L, Snood cap, APRON, Beard cover, 6060, 20210118-BL/X, 20210118-BL/M, Astronaut Cap, PE-SHOC, 6090, 20210118-B/X, 20210118-B/S, 20210112-C/X, 20210118-BL/S1, Mob Cap, XY055, CAP, 20210118-B/M, XY055-XLModel PP Coverall, Microporous Coverall, SMS Coverall, PP+PE Laminated Coverall, PE-GLO, CPE-GLO,TPE-GLO,PVC-GLO, NITRILE-GLO, 43x30cm, 43x60cm, 60x60cm, 75x75cm, 60x90cm, 70x160cm, 80x170cm, 90x180cm, (20-110) x (40-220) cm, Mob Cap, PE Mob Cap, Bouffant Cap, Doctor Cap, Peaked Bouffant Cap, Snood Cap, Astronaut Cap, Nylon Hair Nets, PE-AP, CPE-AP, PVC-AP, PP-AP, PE Shoe Cover, CPE Shoe Cover, NonwovenShoe Cover, Microporous Shoe Cover, PP+CPE ShoeCover
Active
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697457595coverall04EB | Date3 Dec 2022 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Disposable Shoe Cover
- Model / Reference
- PP Coverall, Microporous Coverall, SMS Coverall, PP+PE Laminated Coverall, XY055-XXL, PE-GLO, CPE-GLO, TPE-GLO, PVC-GLO, NITRILE-GLO, 20210118-BL/M1, 43x30cm, 43x60cm, 60x60cm, 75x75cm, 60x90cm, 70x160cm, 80x170cm, 90x180cm, (20-110) x (40-220) cm, 80170, 20210112-C/L, Mob Cap, PE Mob Cap, Bouffant Cap, Doctor Cap, Peaked Bouffant Cap, Snood Cap, Astronaut Cap, Nylon Hair Nets, PE-AP, CPE-AP, PVC-AP, PP-AP, APRON, Beard cover, 6060, 20210118-BL/X, 20210118-BL/M, PE Shoe Cover, CPE Shoe Cover, NonwovenShoe Cover, Microporous Shoe Cover, PP+CPE ShoeCover, PE-SHOC, 6090, 20210118-B/X, 20210118-B/S, 20210112-C/X, 20210118-BL/S1, XY055, CAP, 20210118-B/M, XY055-XL
- Primary DI / UDI-DI
- 16974575956035, 06974575952832, 06974575951132, 06974575952320, 06974575955017, 06974575953006, 06974575955031, 06974575951101, 06974575952030, 06974575952634, 16974575955021, 16974575957001, 06974575951125, 06974575952436, 06974575952139, 06974575952429, 06974575952825, 16974575955007, 06974575956007, 16974575952433, 06974575956038, 16974575955038, 06974575955000, 06974575952238, 16974575952235, 16974575952631, 16974575956028, 06974575957004, 16974575955014, 06974575955024
- Basic UDI-DI
- 697457595coverall04EB, 697457595gloves06RN, 697457595underpad01LJ, 697457595cap08A4, 697457595apron09NP, 697457595shoecover05D7
- EMDN Code
- T0299, T01020204, T04010203, T04010299, T01020201, T0207, T0209, T0208
- Device Class
- Class I
- EU market of registration
- FranceGreeceItaly
Manufacturer details
- EUDAMED SRN
- CN-MF-000002295
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties
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