Isolation gown
by Crown Name Disposable Hygiene Products Fty. Ltd. 4 variants
Ref 411477
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 | Number697312251IG10073 06973122512574 | Date1 Sep 2023 | 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- Withdrawn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
- Model / Reference
- 411477
- Primary DI / UDI-DI
- 06973122512574
- Basic UDI-DI
- 697312251IG10073
- EMDN Code
- T0205 Non-surgical gowns (excluding personal protective equipment - PPE)
- Device Class
- Class I
- Market of Registration
- Norway
Manufacturer details
- EUDAMED SRN
- CN-MF-000008238
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
From the manufacturer
Manufacturer's product page: Disposable Isolation Gown
Other devices from Crown Name Disposable Hygiene Products Fty. Ltd.
See all devices from Crown Name Disposable Hygiene Products Fty. 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