Non-woven Isolation Gowns
by Xinle Huabao Medical Products Co., Ltd. EUDAMED
Active
Ref S, A(Non-sterile)-SModel S, M, L, XL, XXL, XXXL, A(Non-sterile)
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697480258Isolation002Y8 | Date7 Jun 2024 | 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- Withdrawn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
- Excellent Green Shield
- Device Name
- Non-woven Isolation Gowns
- Model / Reference
- S, M, L, XL, XXL, XXXL, A(Non-sterile), A(Non-sterile)-S
- Primary DI / UDI-DI
- 06974802581101
- Basic UDI-DI
- 697480258Isolation002Y8, 697480258Isolation003YA
- EMDN Code
- T0299 Protection drapes and garments - other
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000008893
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Xinle Huabao Medical Products Co., Ltd.
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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