Isolation Gown
by Sword Xiantao Disposable Protective Products Factory 7 variants
Ref ML36326Model 110, 110A, 115, 115A, 115B, 116, 120, 125, 130, 130A, 136, 139, 140, 140A, 150, XS, S, M, L, XL, XXL, XXXL, XXXXL, XXXXXL, Scrub suits, Scrub shirt and pant, Conjoined Type, Split Type, customizable
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 | Number697163167IGZL 16971631674537 | Date21 May 2025 | 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- Withdrawn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
- 110, 110A, 115, 115A, 115B, 116, 120, 125, 130, 130A, 136, 139, 140, 140A, 150, XS, S, M, L, XL, XXL, XXXL, XXXXL, XXXXXL, Scrub suits, Scrub shirt and pant, Conjoined Type, Split Type, customizable, ML36326
- Primary DI / UDI-DI
- 16971631674537
- Basic UDI-DI
- 697163167IGZL
- EMDN Code
- T0299 Protection drapes and garments - other
- Device Class
- Class I
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000009766
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Sword Xiantao Disposable Protective Products Factory
See all devices from Sword Xiantao Disposable Protective Products Factory →
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