Identity
- Trade Name
- BIJOU EUDAMED
- Device Name
- Sterile single use polydioxanone Suture with needle EUDAMED
- Model / Reference
- HYLC21038050F050G07 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809822317707 EUDAMED
- Basic UDI-DI
- B-08809822317707 EUDAMED
- EMDN Code
- H010101010104 MOUNTED POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR TISSUE TRACTION (‘BARBED’) EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Finland 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
Bijou 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-08809822317707 | 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 (1)
- EUDAMED 371eaa55-0b6b-4fa6-bf39-972a37b7f52a 61 fields · synced Jun 17, 2026