Identity
- Trade Name
- EZ-CloseTM EUDAMED
- Device Name
- EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device EUDAMED
- Model / Reference
- EZK01, EZK02, EZK03 EUDAMEDMICT-01-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800021610439 EUDAMED
- Basic UDI-DI
- 88000216EZ9W EUDAMED
- Unit of Use DI
- 08800021600430 EUDAMED
- EMDN Code
- H0101010299 SYNTHETIC ABSORBABLE MULTIFILAMENT SUTURES - OTHER EUDAMED
Classification
- Device Class
- Class III 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
EZ-CloseTM by Medical Impact — 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 | 88000216EZ9W | Class III | Active |
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Manufacturer
- Manufacturer
- Medical Impact
- EUDAMED SRN
- KR-MF-000030613
- Authorised Representative
- Meridius Medical Europe Limited IE-AR-000004258
Sources (1)
- EUDAMED 4ffc2597-a7cb-4de1-b60b-dc618720bcb4 61 fields · synced Jun 19, 2026