Identity
- Trade Name
- EXOFT EUDAMED
- Model / Reference
- 1/2-3770-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800061934878 EUDAMED
- Basic UDI-DI
- B-08800061934878 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
Exoft by CGMBASE 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-08800061934878 | Class III | Active |
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Manufacturer
- Manufacturer
- CGMBASE Co., Ltd.
- EUDAMED SRN
- KR-MF-000033662
- Authorised Representative
- Javitech Consulting GmbH DE-AR-000045915
Sources (1)
- EUDAMED 1365b430-4fc9-4423-a9a0-d7729c8fc833 61 fields · synced Jul 29, 2026