Clean air suit
by Hubei Haixin Protective Products Group Co., Ltd. 28 variants
Ref Pants, LModel Shirt, Pants
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 | Number697314115S00002XL | Date28 May 2026 | 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- Withdrawn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
- Clean air suit
- Model / Reference
- Shirt, Pants, L
- Primary DI / UDI-DI
- 16973141152987
- Basic UDI-DI
- 697314115S00002XL
- EMDN Code
- T0299 Protection drapes and garments - other
- Device Class
- Class I
- Market of Registration
- Sweden
Manufacturer details
- EUDAMED SRN
- CN-MF-000026316
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Hubei Haixin Protective Products Group Co., Ltd
See all devices from Hubei Haixin Protective Products Group Co., Ltd →
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