Disposable Isolation Gowns
by Jiangsu Zhiyu Medical Instrument Co., Ltd. EUDAMED
Active
Ref Rule 1 No IndentModel 160cm 165cm 170cm 175cm 180cm 185cm 190cm 195cm
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69515008GLF001EN | Date12 Sep 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- Device Name
- Disposable Isolation Gowns
- Model / Reference
- 160cm 165cm 170cm 175cm 180cm 185cm 190cm 195cm, Rule 1 No Indent
- Primary DI / UDI-DI
- 06951500816513
- Basic UDI-DI
- 69515008GLF001EN
- EMDN Code
- T0205 Non-surgical gowns (excluding personal protective equipment - PPE)
- Device Class
- Class I
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000024555
- Authorised representative
- Prolinx GmbH DE-AR-000005129
Other devices from Jiangsu Zhiyu Medical Instrument Co., Ltd
See all devices from Jiangsu Zhiyu Medical Instrument Co., Ltd →
Properties
Other properties (12)
- 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