Identity
- Trade Name
- DuraSheath Introducer Sheath System EUDAMED
- Device Name
- DuraSheath Introducer Sheath System EUDAMED
- Model / Reference
- FG-04130-F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251244503062 EUDAMED
- Basic UDI-DI
- 4251244500000013C EUDAMED
- EMDN Code
- C0502 CARDIOVASCULAR INTRODUCER SHEATHS, VALVED EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
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
DuraSheath Introducer Sheath System by Contract Medical International GmbH — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4251244500000013C | Class III | Active |
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Manufacturer
- Manufacturer
- Contract Medical International GmbH
- EUDAMED SRN
- DE-MF-000007409
Sources (1)
- EUDAMED f4458747-2c77-4d97-8bf4-0759967f808f 61 fields · synced Jun 19, 2026