Monofix Pdo
by Samyang Biopharm Corporation South Korea EUDAMED
Ref KM211DS
EMDN H010101010104
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number880936647KM01MT | Date12 Jan 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
EU market availability
Available in 32 countries, as listed in EUDAMED:
- Austria
- Belgium
- Bulgaria
- Croatia
- Cyprus
- Czechia
- Denmark
- Estonia
- Finland
- France
- Germany
- Greece
- Hungary
- Iceland
- Ireland
- Italy
- Latvia
- Liechtenstein
- Lithuania
- Luxembourg
- Malta
- Netherlands
- Northern Ireland
- Norway
- Poland
- Portugal
- Romania
- Slovakia
- Slovenia
- Spain
- Sweden
- Türkiye
Certificates
- 2024-MDR/QS-067/B Amended
Quality management system EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 5 Jan 2026
- Expires
- 12 Dec 2029
- Reason
- Mnf data change
- 2024-MDR/TD-067/B Amended
Technical documentation EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 5 Jan 2026
- Expires
- 12 Dec 2029
- Reason
- Mnf data change
Specification
- Device Name
- Absorbable Knotless Wound Closure Device
- Model / Reference
- KM211DS
- Primary DI / UDI-DI
- 08809366477493
- Basic UDI-DI
- 880936647KM01MT
- EMDN Code
- H010101010104 Mounted polydioxanone monofilament with needle for tissue traction (‘barbed’)
- Device Class
- Class III
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- KR-MF-000037085
- Authorised representative
- Samyang Biopharm Magyarország Kft. HU-AR-000035346
Other devices from Samyang Biopharm Corporation
Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- 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 c2fa62fa-62cf-457e-a7c5-a3c1eab5e37c