Disposable face mask
by ZOGEAR Medical Co., Ltd. 4 variants
Ref PB001-1Model PB001-3
Active
CE MDR
Valid until
1 Oct 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697484312PB001-3CC 06974843124862 | Date14 Oct 2026 | StatusActive |
Certificates
- EPT 0477.MDR.26/6311 Active
Quality management system EU MDR
- Certifier
- Eurofins Product Testing Italy S.r.l. 0477
- Issued
- 2 Oct 2026
- Expires
- 1 Oct 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Face masks
- Model / Reference
- PB001-3, PB001-1
- Primary DI / UDI-DI
- 06974843124862
- Basic UDI-DI
- 697484312PB001-3CC
- EMDN Code
- T020604 Medical use face masks, type II and iir
- Device Class
- Class I
- EU market of registration
- Germany
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 (12)
- 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