Sterile Alginate Wound Dressing
by Qingdao Bright Moon Biomedical Material Co., Ltd. China EUDAMED
Ref AF06Model Non-adhesive Dressing,Self-adhesive Dressing
EMDN M04040201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberCN24/00001294 | Date5 Mar 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- CN24/00001294 Issued
Quality management system EU MDR
- Notified body
- Notified body 1639
- Issued
- 5 Mar 2024
- Expires
- 5 Mar 2029
Specification
- Model / Reference
- Non-adhesive Dressing, Self-adhesive Dressing, AF06
- Primary DI / UDI-DI
- 06934889081505
- Basic UDI-DI
- 69348890SAWD01YL
- EMDN Code
- M04040201 Alginate dressings, non-combined
- Device Class
- Class IIa
Manufacturer details
- EUDAMED SRN
- CN-MF-000021492
- Authorised representative
- Prolinx GmbH DE-AR-000005129
Other devices from Qingdao Bright Moon Biomedical Material Co., Ltd.
See all devices from Qingdao Bright Moon Biomedical Material Co., Ltd. →
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 cc2380bb-70ee-4afb-8fb8-0fcaf817529e