Non-Woven Isolation Gown
by ZOGEAR Medical Co., Ltd. 3 variants
Ref PB015-5Model PB015-1, PB015-2，PB015-3, PB015-4, PB015-5, PB015-6, PB015-7, PB015-8, PB015-9, PB015-10, PB015-11, PB015-12
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 | Number697484312PB015G9 06974843122929 | Date10 Sep 2026 | 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- Withdrawn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
- Isolation gowns
- Model / Reference
- PB015-1, PB015-2，PB015-3, PB015-4, PB015-5, PB015-6, PB015-7, PB015-8, PB015-9, PB015-10, PB015-11, PB015-12
- Primary DI / UDI-DI
- 06974843122929
- Basic UDI-DI
- 697484312PB015G9
- EMDN Code
- T0299 Protection drapes and garments - other
- Device Class
- Class I
- EU market of registration
- Romania
Manufacturer details
- EUDAMED SRN
- CN-MF-000012353
- Authorised representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Other devices from ZOGEAR Medical 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