Dalim Tissen Co., Ltd.
South Korea KR-MF-000020019 Last updated 21 Oct 2026
- Devices
- 61
- Registries
- EUDAMEDFDA 510(k)
- FDA recalls
- 0
Catalogue
TachoFlow Ref CMT-17002
Tissen Universal Applicator – Standard Ref DTEA-25011
Collabarrier Ref AAG-12011
Collabarrier Ref AAG-12004
Diaderm Tape Ref Dalim AS-007053
WA Mem Ref DTG-10002
Collabarrier Ref AAG-12016
Collabarrier Ref AAG-12012
Collagen Wound Dressing Ref K112580
iO mem Ref DTG-10002
Ti-oss Guide Ref DTG-10002
Collabarrier Ref AAG-12006
iO mem Ref DTG-10010
Diaderm Tape Ref Dalim AS-007051
Collabarrier Ref AAG-12002
Diaderm Tape Ref Dalim AS-007031
Diaderm Tape Ref Dalim AS-007049
Diaderm M Ref DTG-10008
CollaStat Ref DCF-17012
Collabarrier Ref AAG-12013
Diaderm M Ref DTG-10005
Diaderm M Ref DTG-10006
Rapiderm Ref Dalim AS-007053
Diaderm Plug Ref DTP-11001
Rapi-Gide Ref DTG-10010
Rapi-Gide Ref DTG-10002
Diaderm M Ref DTG-10002
Collabarrier Ref AAG-12015
WA Mem Ref DTG-10003
Diaderm Tape Ref Dalim AS-007075
Rapi-Gide Ref DTG-10001
Rapiderm Ref Dalim AS-007051
iO mem Ref DTG-10003
Rapi-Gide Ref DTG-10006
Rapiderm Ref Dalim AS-007020
CollaStat Ref DCF-17001
Rapi-Gide(Plug type) Ref DTP-11001
Diaderm Tape Ref Dalim AS-007082
Rapiderm Ref Dalim AS-007082
Collabarrier Ref AAG-12003
Collabarrier Ref AAG-12001
Diaderm Tape Ref Dalim AS-007032
Diaderm Tape Ref Dalim AS-007020
iO mem Ref DTG-10001
Rapi-Gide(Plug type) Ref DTP-11002
Rapi-Gide Ref DTG-10003
iO mem Ref DTG-10006
Diaderm Tape Ref Dalim AS-007028
CollaStat Ref DCF-17002
Collabarrier Ref AAG-12014
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EUDAMED certificates
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
Related companies
Authorised representatives
- Obelis s.a. BE
Notified bodies
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.
Information
- Country
- South Korea
- Address
- 31 , Yeonhui-ro, Mapo-gu, Seoul, South Korea
- Website
- www.dalimtissen.com
- [email protected]
- Phone
- +82 2 3142 0846
- PRRC contact
- Sanghee Bae
- EUDAMED SRN
- KR-MF-000020019