Alpha
by Alpha Solway Ltd United Kingdom EUDAMED
Ref ASR35300AZModel 3530 EMDN T020604
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number50608558843530SM | Date4 Dec 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- 3530 Cup Mask FFP3
- Model / Reference
- 3530, ASR35300AZ
- Primary DI / UDI-DI
- 05060855884908
- Basic UDI-DI
- 50608558843530SM
- EMDN Code
- T020604 Medical use face masks, type ii and iir
- Device Class
- Class I
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- GB-MF-000019916
- Authorised representative
- Globus EMEA Ltd IE-AR-000002785
Other devices from Alpha Solway Ltd
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 4bec44ea-6d84-413f-bc42-0b0323cfe661