Stericlens
by Aurena Laboratories AB Sweden EUDAMED
Ref 301395Model REF 2001
EMDN M04040101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number28620131862-04 | Date10 Jun 2026 | StatusWithdrawn |
Coverage
- Withdrawn
- Not covered
European Union — CE/MDR Withdrawn
Certificates
- 28620131862-04 Supplemented
Quality management system EU MDR
- Notified body
- Intertek Medical Notified Body AB 2862
- Issued
- 10 Jun 2026
- Expires
- 27 Oct 2027
- Reason
- Other
Specification
- Device Name
- Wound Wash
- Model / Reference
- REF 2001, 301395
- Primary DI / UDI-DI
- 07332343300619
- Basic UDI-DI
- 7332343200007B
- Direct Marketing DI
- 07332343300619
- EMDN Code
- M04040101 Saline dressings, non-combined
- Device Class
- Class IIa
- Market of Registration
- Northern Ireland
Manufacturer details
- EUDAMED SRN
- SE-MF-000002890
Other devices from Aurena Laboratories AB
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 37f994fe-09d9-417c-ab65-913a98ba94a3