Surgical Gown
by Hubei Gongbing Medical Equipment Co., LTD
Ref SG-SMS-003Model SG-PP-001,SG-PPPE-002,SG-SMS-003,SG-CPE-004,SG-SF-005
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 | Number697431806SG001FE 06974318063030 | Date12 Jun 2023 | 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- Withdrawn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
- Surgical Gown
- Model / Reference
- SG-PP-001, SG-PPPE-002, SG-SMS-003, SG-CPE-004, SG-SF-005
- Primary DI / UDI-DI
- 06974318063030
- Basic UDI-DI
- 697431806SG001FE
- EMDN Code
- T020401 Standard surgical gowns
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000010771
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Hubei Gongbing Medical Equipment 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