Neo-natal HMEF
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Neo-natal HMEF EUDAMEDFDA UDI
- Generic Name
- Heat/moisture exchanger, single-use FDA UDI
- Device Name
- Humidification Systems EUDAMED
- Model / Reference
- 9080/100ZAUA001/0001 EUDAMED9080/100BTUA001/0001 EUDAMED9080/100BAUA001/0001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060120951564 EUDAMED05060120952806 EUDAMED15060120951967 FDA UDI
- Basic UDI-DI
- 506012095Cat175 EUDAMED
- 510(k) Number
- K033008 FDA UDI
- FDA Product Code
- CAH FDA UDI
- EMDN Code
- R040102 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS EUDAMED
- GMDN Term
- Heat/moisture exchanger, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5260 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Heat/moisture exchanger, single-use
Neo-natal HMEF by Gvs Filter Technology Uk Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Heat/moisture exchanger, single-use.
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Cleared under the same submission
K033008 also covers:
- AirLife™ — Airlife, Inc.
- AQUESURE FILTER HUMIDIFIER — BOMImed Inc
- ECO HMEF — GVS FILTER TECHNOLOGY UK LTD
- ECO Maxi Filter — GVS FILTER TECHNOLOGY UK LTD
- ECO Range — GVS FILTER TECHNOLOGY UK LTD
- HEPA Ventilation Filter — GVS FILTER TECHNOLOGY UK LTD
- High Deadspace Body — GVS FILTER TECHNOLOGY UK LTD
- L4 New Intake Filter — GVS FILTER TECHNOLOGY UK LTD
- Maxi-Pleat — GVS FILTER TECHNOLOGY UK LTD
- Multi-Vent — GVS FILTER TECHNOLOGY UK LTD
- Multi-Vent — GVS FILTER TECHNOLOGY UK LTD
- Multi-Vent — GVS FILTER TECHNOLOGY UK LTD
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Gvs Filter Technology Uk Ltd
Sources (3)
- FDA UDI 0168932d-0285-4692-b6e7-df9554eaab51 34 fields · synced Jul 25, 2026
- EUDAMED e561c525-920c-494c-9537-7a9938ad4b2d 61 fields · synced Jul 9, 2026
- EUDAMED 190463ba-125d-4b1e-97e6-7a85dcec96be 61 fields · synced Jul 25, 2026