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Eco Hmef
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 4331/01ZAUA001/0001Ref 4333/01BAUA038/0001Ref 4333/01BAUA076/0001Ref 4333/01BAUA001/0001Ref 4333/01BAUA002/0001Ref 4333/01ZAUA001/0001
Identity
- Trade Name
- ECO HMEF EUDAMEDFDA UDI
- Generic Name
- Heat/moisture exchanger, single-use FDA UDI
- Device Name
- Humidification Systems EUDAMED
- Model / Reference
- 4331/01ZAUA001/0001 EUDAMED4333/01BAUA038/0001 EUDAMED4333/01BAUA076/0001 EUDAMED4333/01BAUA001/0001 EUDAMED4333/01BAUA002/0001 EUDAMED4333/01ZAUA001/0001 EUDAMED4331/01BAUA001/0001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060120957825 EUDAMED05060120956972 EUDAMED05060120957016 EUDAMED05060120953490 EUDAMED05060120959843 EUDAMED05060120957320 EUDAMED15060120950106 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Heat/moisture exchanger, single-use
Eco 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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Cleared under the same submission
K033008 also covers:
- AirLife™ — Airlife, Inc.
- AQUESURE FILTER HUMIDIFIER — BOMImed Inc
- 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
- Multi-Vent — GVS FILTER TECHNOLOGY UK LTD
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 (7)
- FDA UDI 7bbd17a6-0017-484e-9c47-b01ef41f0e02 34 fields · synced Aug 3, 2026
- EUDAMED 01cb6f51-eecc-44a4-af5e-a41c95acf2a7 61 fields · synced Jul 8, 2026
- EUDAMED d4a17a99-edf3-414d-9833-ba34a2b1815a 61 fields · synced Jul 16, 2026
- EUDAMED 0819c063-ac9f-4c48-b778-95c23cea5787 61 fields · synced Jul 16, 2026
- EUDAMED 345c4d40-7824-4d0b-a735-8592f3a57127 61 fields · synced Jul 30, 2026
- EUDAMED 00cad219-6b9d-4e30-936e-298defd9f7c9 61 fields · synced Aug 2, 2026
- EUDAMED 6a32cc27-3b8d-4b75-9338-69d7f0bfb521 61 fields · synced Aug 3, 2026