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High Flow Insufflation Kit
EUDAMEDClass IIa (EU MDR)
Ref 6421/04BGKBTUA001/0001
Identity
- Trade Name
- High Flow Insufflation Kit EUDAMED
- Device Name
- Ventilation Filters EUDAMED
- Model / Reference
- 6421/04BGKBTUA001/0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060120950680 EUDAMED
- Basic UDI-DI
- 506012095Cat47B EUDAMED
- EMDN Code
- R060299 HUMIDIFICATION SYSTEMS - OTHER 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
High Flow Insufflation Kit 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 | 506012095Cat47B | 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 09c27052-4e8f-45be-bd8b-0205890a5745 61 fields · synced Jul 16, 2026