Identity
- Trade Name
- MAXI HME Pleat EUDAMED
- Device Name
- Humidification Systems EUDAMED
- Model / Reference
- 4244/711BSSA100/0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060511620123 EUDAMED
- Basic UDI-DI
- 506012095Cat175 EUDAMED
- EMDN Code
- R040102 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
MAXI HME Pleat by GVS Filter Technology UK Ltd — 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 | 506012095Cat175 | Class IIa | Active |
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Manufacturer
- Manufacturer
- GVS Filter Technology UK Limited
- EUDAMED SRN
- UK-MF-000045036
- Authorised Representative
- GVS S.p.A. IT-AR-000028148
Sources (1)
- EUDAMED 370c9d3f-5988-407c-a4af-b32ba289ff7a 61 fields · synced Sep 17, 2026