Disposable Isolation Gown
by Xiantao Softmed Protective Products Co., Ltd EUDAMED
Active
Ref M, 130x160cm, XXXXXXL, XXXL, XXXXXL, 120x140cm, 115x137cm, XXL, SModel 110x130 cm, 115x137cm, 120x140cm, 125x145cm, 130x160cm, S, M, L, XL, XXL, XXXL, XXXXL, XXXXXL, XXXXXXL
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697543051DIG01DB | Date7 Jul 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Disposable Isolation Gown
- Model / Reference
- 110x130 cm, 115x137cm, 120x140cm, 125x145cm, 130x160cm, S, M, L, XL, XXL, XXXL, XXXXL, XXXXXL, XXXXXXL
- Primary DI / UDI-DI
- 06975430513069, 06975430513045, 06975430513137, 06975430513106, 06975430513120, 06975430513021, 06975430513014, 06975430513090, 06975430513052
- Basic UDI-DI
- 697543051DIG01DB
- EMDN Code
- T0299 Protection drapes and garments - other
- Device Class
- Class I
- Market of Registration
- SpainItalyAustria
Manufacturer details
- EUDAMED SRN
- CN-MF-000011460
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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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