Isolation gown
by Linye Health Tech(Ningbo)Co., Ltd EUDAMED
Active
Ref LY-IG12Model LY-IG01
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697539440LYIG00V8 | Date5 Mar 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Model / Reference
- LY-IG01, LY-IG12
- Primary DI / UDI-DI
- 06975394401075
- Basic UDI-DI
- 697539440LYIG00V8
- EMDN Code
- T0299 Protection drapes and garments - other
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000024232
- Authorised representative
- Sungo Cert GmbH DE-AR-000010869
Other devices from Linye Health Tech(Ningbo)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