Identity
- Trade Name
- EXOFT EUDAMED
- Model / Reference
- 1/2-3130-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800061935028 EUDAMED
- Basic UDI-DI
- B-08800061935028 EUDAMED
- EMDN Code
- H010101010101 POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR OPEN SURGERY EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Exoft by CGMBASE Co., Ltd. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Polyester suture, bioabsorbable, monofilament, non-antimicrobial.
- Monoswift — RIVERPOINT MEDICAL LLC · Class II
- DemeDIOX — DemeTECH Corp · Class II
- DemeCAPRONE — DemeTECH Corp · Class II
- DemeCAPRONE — DemeTECH Corp · Class II
- WEGO-PDO Absorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc. · Class II
- Maxon — Covidien LP · Class II
- DemeCAPRONE — DemeTECH Corp · Class II
- DemeCAPRONE — DemeTECH Corp · Class II
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-08800061935028 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CGMBASE Co., Ltd.
- EUDAMED SRN
- KR-MF-000033662
- Authorised Representative
- Javitech Consulting GmbH DE-AR-000045915
Sources (1)
- EUDAMED 2b9014c2-7fbe-463b-89a4-13e512dbe9df 61 fields · synced Jul 25, 2026