Haika
by Globus (Shetland) Ltd United Kingdom EUDAMED
Ref HAK8007
EMDN T020604
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number506068049HAK80072K | Date1 Sep 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Haika Mxiir HAK8007
- Model / Reference
- HAK8007
- Primary DI / UDI-DI
- 05060680496352
- Basic UDI-DI
- 506068049HAK80072K
- 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-000007384
- Authorised representative
- Globus EMEA Ltd IE-AR-000002785
Other devices from Globus (Shetland) 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 3e3fb053-44a7-49f1-993a-7a87f886a1de