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Disposable Prefilled Bubble Humidifier
EUDAMEDClass I (EU MDR)
Ref TF-CDH-003/09Model CDH500
Identity
- Device Name
- Disposable Prefilled Bubble Humidifier EUDAMED
- Model / Reference
- CDH500 EUDAMEDTF-CDH-003/09 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 19554100244324 EUDAMED
- Basic UDI-DI
- 955410024432CDH500P5 EUDAMED
- Direct Marketing DI
- 19554100244324 EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I 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
Category: Pulmonary function analysis system, adult
Disposable Prefilled Bubble Humidifier by Star Medik Sdn. Bhd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 955410024432CDH500P5 | Class I | 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 (1)
- EUDAMED 58f6bf92-fb9f-47d3-ad11-670bb40c0873 61 fields · synced Jul 9, 2026