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Breathing Circuit & Accessories (Bain Circuit +2 more)
EUDAMEDClass IIa (EU MDR)
Ref 20468Model HME Filter
Identity
- Trade Name
- Breathing Circuit & Accessories (Bain Circuit, Ventilator Circuit, HME Filter) EUDAMED
- Device Name
- Breathing Circuit & Accessories (Bain Circuit, Ventilator Circuit, HME Filter) EUDAMED
- Model / Reference
- HME Filter EUDAMED20468 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095204689 EUDAMED
- Basic UDI-DI
- 890209520424EB EUDAMED
- EMDN Code
- R040199 VENTILATION FILTERS - OTHER EUDAMED
- Models / Variants
- Bain Circuit EUDAMEDVentilator Circuit EUDAMEDHME Filter 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
Category: Microbial medical gas filter, single-use
Breathing Circuit & Accessories (Bain Circuit +2 more) by Poly Medicure Limited — Class IIa — MDR — listed in EUDAMED — 3 models — 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
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 | 890209520424EB | Class IIa | Active |
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Manufacturer
- Manufacturer
- Poly Medicure Limited
- EUDAMED SRN
- IN-MF-000043009
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED c735ebc4-16ff-4584-96c0-d92f9fef2350 61 fields · synced Sep 18, 2026