isolation gown
by Wuhan Orient Honest International Trade Co., Ltd 11 variants
Ref OH-4001Model OH-3000, OH-4000, OH-4001, OH-5000, OH-5003R, OH-7001, OH-7002, OH-0010, OH-0011, OH-0012, OH-0013
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 | Number697680378IG01P4 | Date13 Oct 2023 | StatusActive |
Certificates
No notified-body 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- Withdrawn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
- isolation gown
- Model / Reference
- OH-3000, OH-4000, OH-4001, OH-5000, OH-5003R, OH-7001, OH-7002, OH-0010, OH-0011, OH-0012, OH-0013
- Primary DI / UDI-DI
- 69768037840015
- Basic UDI-DI
- 697680378IG01P4
- EMDN Code
- T0299 Protection drapes and garments - other
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000037844
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Wuhan Orient Honest International Trade Co., Ltd
See all devices from Wuhan Orient Honest International Trade 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