Identity
- Trade Name
- EZ REGULAR I011 EUDAMED
- Device Name
- Sterile IV EZ Regulator sets EUDAMED
- Model / Reference
- MTEZ-UM-E00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809289430223 EUDAMED
- Basic UDI-DI
- 880928943EZ4U EUDAMED
- EMDN Code
- A03010103 INFUSION CONTROLLERS WITH FLOW REGULATOR EUDAMED
Classification
- Device Class
- Class I 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ez Regular I011 by Meinntech Co., Ltd. — Class I — 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 | 880928943EZ4U | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Meinntech Co., Ltd.
- EUDAMED SRN
- KR-MF-000027366
- Authorised Representative
- JaviTech e.K. DE-AR-000005875
Sources (1)
- EUDAMED a13c0025-cc31-4f2a-905e-8d00c1562a25 61 fields · synced Jun 19, 2026