Dalim Tissen Co., Ltd.
Active in EUDAMEDSouth Koreafrom SRN EUDAMED SRN KR-MF-000020019
- Devices
- 61
- Registrations
- EUDAMED
Catalogue
Rapiderm Ref Dalim AS-007075
Diaderm M Ref DTG-10010
Diaderm Plug Ref DTP-11002
Rapiderm Ref Dalim AS-007080
Diaderm Tape Ref Dalim AS-007080
Collabarrier Ref AAG-12005
Ti-oss Guide Ref DTG-10010
CollaStat Ref DCF-17003
Rapiderm Ref Dalim AS-007028
Rapiderm Ref Dalim AS-007032
Rapiderm Ref Dalim AS-007031
Showing 51-61 of 61
Company details
- EUDAMED SRN
- KR-MF-000020019
- EU VAT number
- 105-86-88474
- EUDAMED status
- Active
- EUDAMED registered name
- Dalim Tissen Co., Ltd.
- Registered address
- 31, Yeonhui-ro, Mapo-gu, 03982, Seoul, South Korea
- Website
- www.dalimtissen.com
- [email protected]
- Phone
- +82 2 3142 0846
- PRRC contact
- Sanghee Bae
EUDAMED certificates
4 certificates4 valid, 0 expiredMDR 4next expiry 12 Sep 2029
3EC International a.s. 2265 4 certificates
- 2024-MDR/QS-055/B Amended
Quality management system EU MDR
- Issued
- 11 Aug 2026
- Expires
- 12 Sep 2029
- Reason
- Mnf data change
- 2024-MDR/QS-056/C Amended
Quality management system EU MDR
- Issued
- 11 Aug 2026
- Expires
- 12 Sep 2029
- Reason
- Mnf data change
- 2024-MDR/TD-055/B Amended
Technical documentation EU MDR
- Issued
- 11 Aug 2026
- Expires
- 12 Sep 2029
- Reason
- Mnf data change
- 2024-MDR/TD-056/C Amended
Technical documentation EU MDR
- Issued
- 11 Aug 2026
- Expires
- 12 Sep 2029
- Reason
- Mnf data change
What Dalim Tissen Co., Ltd. makes
Dalim Tissen Co., Ltd. manufactures medical devices including adhesive tapes (such as Diaderm Tape and Rapiderm), wound dressings (including collagen-based and hemostatic products like Collagen Wound Dressing and CollaStat), and surgical barriers (such as Collabarrier). Their portfolio also includes bone graft guides (Ti-oss Guide) and wound management membranes (WA Mem and Diaderm M).
The company’s devices are classified under EU Class III and Class U (custom devices) and are listed in the EUDAMED registry and the FDA’s 510(k) database. The manufacturer is based in South Korea.