Identity
- Trade Name
- Star EUDAMED
- Device Name
- Sterile single use polydioxanone Suture with needle EUDAMED
- Model / Reference
- MP27050070G EUDAMEDMP29060090H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809822314164 EUDAMED08809822319817 EUDAMED
- Basic UDI-DI
- B-08809822314164 EUDAMEDB-08809822319817 EUDAMED
- EMDN Code
- H010101010104 MOUNTED POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR TISSUE TRACTION (‘BARBED’) EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMEDSpain 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
Star 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-08809822314164 | 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 6fc6178c-9c3a-45f6-b59b-73e92d855e60 61 fields · synced Aug 3, 2026
- EUDAMED 0fe1527d-9633-4615-8139-a0ac8094ba48 61 fields · synced May 17, 2026