Identity
- Trade Name
- Countourel EUDAMED
- Device Name
- Sterile Single Use Absorbable Polydioxanone Suture with Needle EUDAMED
- Model / Reference
- JSFE-19-131W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800047817461 EUDAMED
- Basic UDI-DI
- B-08800047817461 EUDAMED
- EMDN Code
- H010101010104 MOUNTED POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR TISSUE TRACTION (‘BARBED’) EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Austria 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
Countourel by J world Co., Ltd. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Unknown
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800047817461 | Class III | Unknown |
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Manufacturer
- Manufacturer
- J world Co., Ltd.
- EUDAMED SRN
- KR-MF-000026588
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (1)
- EUDAMED fdc4b03c-e4b1-4588-9598-f24ff090d827 61 fields · synced Jun 18, 2026