Identity
- Trade Name
- Ultra V Mono EUDAMED
- Device Name
- Sterile single use polydioxanone Suture with needle EUDAMED
- Model / Reference
- MP29038050H EUDAMEDMP29025030H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809822316441 EUDAMED08809822316427 EUDAMED
- Basic UDI-DI
- B-08809822316441 EUDAMEDB-08809822316427 EUDAMED
- EMDN Code
- H010101010104 MOUNTED POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR TISSUE TRACTION (‘BARBED’) EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ultra V Mono by 21 Century Medical Co., Ltd. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809822316441 | Class III | Active |
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Manufacturer
- Manufacturer
- 21 Century Medical Co., Ltd.
- EUDAMED SRN
- KR-MF-000009204
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (2)
- EUDAMED ea29ac39-3477-45c8-9302-3ddd10e01f11 61 fields · synced Oct 6, 2026
- EUDAMED fbc01892-16b3-4ffa-8c57-983c9df246a1 61 fields · synced May 18, 2026