Identity
- Device Name
- Infusion Sets EUDAMED
- Model / Reference
- 108.0200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05607716002004 EUDAMED
- Basic UDI-DI
- 56077161007U EUDAMED
- EMDN Code
- A03010103 INFUSION CONTROLLERS WITH FLOW REGULATOR EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Portugal 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
Infusion Sets by Produtos Médicos Hospitalares, SA — Class IIa — 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 | 56077161007U | Class IIa | Active |
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Manufacturer
- Manufacturer
- Produtos Médicos Hospitalares, SA
- EUDAMED SRN
- PT-MF-000007631
Sources (1)
- EUDAMED 5cbe9ec5-f4bf-477b-9be9-d3c0622b3e28 61 fields · synced Jun 18, 2026