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Breathing Circuit & Accessories - Ventilator Circuit
EUDAMEDClass IIa (EU MDR)
Ref 20421Model Ventilator Circuit
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
- Ventilator Circuit EUDAMED20421 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095204214 EUDAMED
- Basic UDI-DI
- 890209520415EA EUDAMED
- EMDN Code
- R02010101 BREATHING CIRCUITS, W/O WATER TRAP 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
Breathing Circuit & Accessories - Ventilator Circuit by Poly Medicure Limited — Class IIa — MDR — listed in EUDAMED — 3 models — 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 | 890209520415EA | 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 7300c7a3-6066-42b9-bd05-205ad67cd22c 61 fields · synced Jul 27, 2026