Identity
- Trade Name
- Bio Meyisun EUDAMED
- Device Name
- Sterile single use polydioxanone Suture with needle EUDAMED
- Model / Reference
- LF23050120E EUDAMEDLFA23050070E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809822312627 EUDAMED08809822312641 EUDAMED
- Basic UDI-DI
- B-08809822312627 EUDAMEDB-08809822312641 EUDAMED
- EMDN Code
- H010101010104 MOUNTED POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR TISSUE TRACTION (‘BARBED’) EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Italy 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
Bio Meyisun 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-08809822312627 | 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 c72ab086-464a-42e7-b465-d145f91913e8 61 fields · synced Jun 20, 2026
- EUDAMED 451b131d-040e-489f-8077-0f5d54b98905 61 fields · synced May 18, 2026