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ECO Maxi Filter
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 4222/702BSSA100/0001Ref 4244/701BAUA001/0001Ref 4222/701BAUA001/0001Ref 4220/04BAUA001/0001Ref 4220/04BSSA001/0001Ref 4222/701BSSA100/0001Ref 4222/701BUUA001/0001Ref 4222/702BRSA001/0001Ref 4222/703BSSA001/0001Ref 4222/702BAUA001/0001Ref 4222/703BRSA001/0001Ref 4222/702BSSA001/0001Ref 4222/701BRSA001/0001Ref 4222/702BAUA024/0001
Identity
- Trade Name
- ECO Maxi Filter EUDAMEDFDA UDIMAXI Maxi Filter EUDAMEDECO FILTER EUDAMED
- Generic Name
- Microbial medical gas filter, single-use FDA UDI
- Device Name
- Respiratory Filters - Various EUDAMED
- Model / Reference
- 4222/701BAUA001/0001 EUDAMEDFDA UDI4222/702BSSA100/0001 EUDAMED4244/701BAUA001/0001 EUDAMED4220/04BAUA001/0001 EUDAMED4220/04BSSA001/0001 EUDAMED4222/701BSSA100/0001 EUDAMED4222/701BUUA001/0001 EUDAMED4222/702BRSA001/0001 EUDAMED4222/703BSSA001/0001 EUDAMED4222/702BAUA001/0001 EUDAMED4222/703BRSA001/0001 EUDAMED4222/702BSSA001/0001 EUDAMED4222/701BRSA001/0001 EUDAMED4222/702BAUA024/0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060511624114 EUDAMED05060120953377 EUDAMED05060120950772 EUDAMED05060120953322 EUDAMED05060511622585 EUDAMED05060511620338 EUDAMED05060120952271 EUDAMED05060511621359 EUDAMED05060511622622 EUDAMED05060120950208 EUDAMED05060511621366 EUDAMED05060511621793 EUDAMED05060511621342 EUDAMED05060120958112 EUDAMED15060120950779 FDA UDI
- Basic UDI-DI
- 506012095Cat277 EUDAMED
- 510(k) Number
- K033008 FDA UDI
- FDA Product Code
- CAH FDA UDI
- EMDN Code
- R040199 VENTILATION FILTERS - OTHER EUDAMED
- GMDN Term
- Microbial medical gas filter, 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 UDIEUDAMED
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: Microbial medical gas filter, single-use
ECO Maxi Filter by Gvs Filter Technology Uk Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Microbial medical gas filter, single-use.
- ECO slimline — GVS Filter Technology UK Ltd · Class IIa
- Disposable Heat and Moisture Exchanger Filters — NINGBO HUAKUN MEDICAL EQUIPMENT CO.,LTD · Class IIa
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- Ventlab — Ventlab Corp. · Class II
- Disposable Heat and Moisture Exchanger Filters — NINGBO HUAKUN MEDICAL EQUIPMENT CO.,LTD · Class IIa
- Ventlab — Ventlab Corp. · Class II
- Pentair — Pentair Filtration Solutions · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
Cleared under the same submission
K033008 also covers:
- AirLife™ — Airlife, Inc.
- AQUESURE FILTER HUMIDIFIER — BOMImed Inc
- ECO HMEF — 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 (15)
- FDA UDI f5eb3927-e78f-47a4-8c5f-71f18da4c4f3 34 fields · synced Aug 4, 2026
- EUDAMED b2c97834-0f25-49c9-8dbe-da07ca06ab59 61 fields · synced Jul 9, 2026
- EUDAMED e718cea6-ed9f-45e9-bf7b-7f8bf9af641b 61 fields · synced Jul 9, 2026
- EUDAMED fd735684-c1b9-4dbc-a195-7f726348152d 61 fields · synced Jul 10, 2026
- EUDAMED d4e251f3-db72-4676-83d4-531fbd2b5a74 61 fields · synced Jul 11, 2026
- EUDAMED f0ab97ee-7f51-415b-b572-f232712eb41b 61 fields · synced Jul 12, 2026
- EUDAMED f93a8cba-422f-479e-bfd0-dddccbc66c83 61 fields · synced Jul 12, 2026
- EUDAMED e312355b-fe3d-4546-8b4b-e4b425ecc219 61 fields · synced Jul 14, 2026
- EUDAMED 30083f10-8938-47cc-8dad-9d269634d36b 61 fields · synced Jul 17, 2026
- EUDAMED 8626884d-dcb6-45c8-aad4-5b6a5f08d037 61 fields · synced Jul 20, 2026
- EUDAMED 7eae6cc4-b2f9-4de3-914e-3572722b10c2 61 fields · synced Jul 26, 2026
- EUDAMED 84540874-716e-442e-afe6-256169b2acaa 61 fields · synced Jul 27, 2026
- EUDAMED d4804db1-a051-4cf8-a330-fb679b1014c2 61 fields · synced Jul 30, 2026
- EUDAMED a3c3c0f0-dbbf-4f0e-9f34-402fe4227f0c 61 fields · synced Jul 30, 2026
- EUDAMED 511efd9e-94ea-48f0-afcb-68965b3f120f 61 fields · synced Aug 4, 2026