Res-Q 300 Plus Sensitive Surgical Face Mask, Type Iir, Loops, Yellow
by Cross Protection (M) Sdn Bhd
Ref 2-426ELY, 2-426ELO, 2-426ELG, 2-426ELP
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 | Number955571350FACEMASKWM | Date18 Jan 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- Withdrawn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
- Trade Name
- Res-Q 300 Plus "Sensitive" Surgical Face Mask, Type Iir, Loops, YellowRes-Q 300 Plus "Sensitive" Surgical Face Mask, Type Iir, Loops, OrangeRes-Q 300 Plus "Sensitive" Surgical Face Mask, Type Iir, Loops, GreenRes-Q 300 Plus "Sensitive" Surgical Face Mask, Type Iir, Loops, Pink
- Device Name
- Surgical Face Mask, Type Iir, Loops, Blue
- Model / Reference
- 2-426ELY, 2-426ELO, 2-426ELG, 2-426ELP
- Primary DI / UDI-DI
- 09555713504129, 09555713504143, 09555713504105, 09555713504136
- Basic UDI-DI
- 955571350FACEMASKWM
- EMDN Code
- T020604 Medical use face masks, type II and iir
- Device Class
- Class I
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- MY-MF-000029344
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Cross Protection (M) Sdn Bhd
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