Lisen International
by Wuhan Zonsen Medical Products Co., Ltd
Ref ZSG1001Model ZSG
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 | Number697199986ZSG5Y 06971999860545 | Date20 Oct 2021 | 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- Withdrawn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
- ZSG, ZSG1001
- Primary DI / UDI-DI
- 06971999860545
- Basic UDI-DI
- 697199986ZSG5Y
- EMDN Code
- T020401 Standard surgical gowns
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000008034
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Wuhan Zonsen Medical Products Co., Ltd
See all devices from Wuhan Zonsen Medical Products 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