Rapiderm
by Dalim Tissen Co., Ltd. EUDAMED
Active
Ref Dalim AS-007028, Dalim AS-007049
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number2024-MDR/QS-055/B | Date11 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 2024-MDR/QS-055/B Amended
Quality management system EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 11 Aug 2026
- Expires
- 12 Sep 2029
- Reason
- Mnf data change
- 2024-MDR/TD-055/B Amended
Technical documentation EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 11 Aug 2026
- Expires
- 12 Sep 2029
- Reason
- Mnf data change
Specification
- Device Name
- Collagen Wound Dressing
- Model / Reference
- Dalim AS-007028, Dalim AS-007049
- Primary DI / UDI-DI
- 08809201010830, 08809201010090
- Basic UDI-DI
- 880920101DALIMASCX, B-08809201010090
- EMDN Code
- M04041001 Animal-derived collagen dressings, non-combined
- Device Class
- Class III
- Market of Registration
- BulgariaSpain
Manufacturer details
- EUDAMED SRN
- KR-MF-000020019
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Dalim Tissen Co., Ltd.
Properties
Other properties (10)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No