Medical Face Mask
by Hubei Mingerkang Health & Safety Appliances Co., Ltd.
Ref HYKY-01511Model Flat-type: 19.5*9.5cm, 17.5*9.5cm, 14.5*9.5cm, 12.5*9cm, other sizes customizable upon request
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 | Number697047812A00014N 06970478121153 | Date18 Jun 2025 | 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- Withdrawn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 Medical/Surgical Face Mask
- Model / Reference
- Flat-type: 19.5*9.5cm, 17.5*9.5cm, 14.5*9.5cm, 12.5*9cm, other sizes customizable upon request, HYKY-01511
- Primary DI / UDI-DI
- 06970478121153
- Basic UDI-DI
- 697047812A00014N
- Unit of Use DI
- 06970478121146
- EMDN Code
- T020604 Medical use face masks, type II and iir
- Device Class
- Class I
- EU market of registration
- Czechia
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