Disposable Nonwoven Isolation Gown
by Hubei Mingerkang Health & Safety Appliances Co., Ltd. 19 variants
Ref ME 4009 Visitor GownModel S, M, L, XL, XXL, XXXL
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697047812C00015C 06970478120095 | Date14 May 2024 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Disposable Nonwoven Isolation Gown
- Model / Reference
- S, M, L, XL, XXL, XXXL, ME 4009 Visitor Gown
- Primary DI / UDI-DI
- 06970478120095
- Basic UDI-DI
- 697047812C00015C
- EMDN Code
- T0205 Non-surgical gowns (excluding personal protective equipment - PPE)
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000003241
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
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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