Identity
- Device Name
- Pressure Infusion Cuff EUDAMED
- Model / Reference
- 1PPI30500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04714127860244 EUDAMED
- Basic UDI-DI
- 471412786PP1HW EUDAMED
- EMDN Code
- Z12030301 INFUSION PUMPS EUDAMEDA088001 PRESSURE INFUSION CUFFS, SINGLE-USE EUDAMEDZ12019007 IRRIGATORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
No
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
Pressure Infusion Cuff by Unimax Medical Systems Inc. — 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 | 471412786PP1HW | Class I | Active |
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Manufacturer
- Manufacturer
- Unimax Medical Systems Inc.
- EUDAMED SRN
- TW-MF-000008895
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (3)
- EUDAMED 5b8886a9-bfb4-4a52-b9ea-6495a234768f 61 fields · synced Oct 8, 2026
- EUDAMED 62ebe595-b3be-486d-9def-c645befbcf48 61 fields · synced Jun 18, 2026
- EUDAMED 521a6230-3407-41e4-9be9-3f1bc670894c 61 fields · synced Oct 8, 2026