Identity
- Trade Name
- Oxygen Concentrator Filter EUDAMED
- Device Name
- Gas and Suction Filters EUDAMED
- Model / Reference
- 4100/20LAUC001/0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060120955135 EUDAMED
- Basic UDI-DI
- 506012095Class1L9 EUDAMED
- EMDN Code
- R040199 VENTILATION FILTERS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
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
Category: Microbial medical gas filter, single-use
Oxygen Concentrator Filter by GVS Filter Technology UK Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Microbial medical gas filter, single-use.
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- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
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 | 506012095Class1L9 | Class I | 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 d62e9793-b780-46dd-bf3d-9899abf0fc12 61 fields · synced Aug 3, 2026