Identity
- Device Name
- Pressure Infusion Cuff EUDAMED
- Model / Reference
- 1PPI31000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04714127860251 EUDAMED
- Basic UDI-DI
- 471412786PP1HW EUDAMED
- EMDN Code
- Z12030301 INFUSION PUMPS EUDAMEDA088001 PRESSURE INFUSION CUFFS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Norway EUDAMEDSweden 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 (2)
- EUDAMED b386a0bf-abfb-4298-9bd6-894549f367f3 61 fields · synced Oct 7, 2026
- EUDAMED 1ba6d937-277f-4541-a3b4-2d3accbf610e 61 fields · synced Jun 18, 2026