Isolation gown
by Xiantao Fortune Medical Supplies Co., Ltd. EUDAMED 3 variants
Active
Ref 2169721
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697439066fy-1016C | Date31 Mar 2022 | 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- Withdrawn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
- Trade Name
- Isolation gownIsolatioin gown
- Model / Reference
- 2169721
- Primary DI / UDI-DI
- 06974390660066, 16974390660445, 16974390660438, 16974390660179, 16974390660162, 16974390660421
- Basic UDI-DI
- 697439066fy-1016C
- Unit of Use DI
- 06974390660448, 06974390660431, 06974390660172, 06974390660165, 06974390660424
- EMDN Code
- T0203 Dressing and assistance kits
- Device Class
- Class I
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000003236
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Xiantao Fortune Medical Supplies Co., Ltd.
See all devices from Xiantao Fortune Medical Supplies 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