Isolation Gown
by Sword Xiantao Disposable Protective Products Factory 7 variants
Ref XSModel XS S M L XL 2XL 3XL 4XL 5XL
Active
CE MDR
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 | Number697163167IGSS6 16971631679075 | Date31 Dec 2024 | 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- Withdrawn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
- Isolation Gown
- Model / Reference
- XS S M L XL 2XL 3XL 4XL 5XL, XS
- Primary DI / UDI-DI
- 16971631679075
- Basic UDI-DI
- 697163167IGSS6
- EMDN Code
- T030501 Operation rooms and visit rooms hygienic covers
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000009766
- 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