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Bubble Humidifier with Occlusion Protection
EUDAMEDClass IIa (EU MDR)
Ref 9410-006
Identity
- Trade Name
- Bubble Humidifier with Occlusion Protection EUDAMED
- Device Name
- Non-heated respiratory humidifier EUDAMED
- Model / Reference
- 9410-006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051977002530 EUDAMED
- Basic UDI-DI
- B-05051977002530 EUDAMED
- EMDN Code
- R060202 OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Portugal EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bubble Humidifier with Occlusion Protection by Penlon Limited — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05051977002530 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Penlon Limited
- EUDAMED SRN
- GB-MF-000025115
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED fb0f0d2e-b6d2-419a-a386-e5d7e8ed4f4a 61 fields · synced Jul 12, 2026