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Sterile Disposable Prefilled Bubble Humidifier
EUDAMEDClass IIa (EU MDR)
Ref TF-CDH-003/09Model CDH 340, CDH 350, CDH 450, & CDH 500
Identity
- Device Name
- Sterile Disposable Prefilled Bubble Humidifier EUDAMED
- Model / Reference
- CDH 340, CDH 350, CDH 450, & CDH 500 EUDAMEDTF-CDH-003/09 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 95541002443276 EUDAMED95541002443030 EUDAMED
- Basic UDI-DI
- 95541002443CDHUD EUDAMED
- EMDN Code
- R060202 OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania 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
Sterile Disposable Prefilled Bubble Humidifier by Star Medik Sdn. Bhd. — 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 | 95541002443CDHUD | Class IIa | Active |
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Manufacturer
- Manufacturer
- Star Medik Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000025171
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED af1c1eeb-404e-4824-9e73-2e8ba0c220b5 61 fields · synced Jul 11, 2026
- EUDAMED 3b0cacd8-8498-4d65-9b94-4ebaecc619f4 61 fields · synced May 19, 2026