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Aerochamber Plus Flow-Vu
EUDAMEDClass I (EU MDR)
Ref 108509/108509109060Model 108509
Identity
- Trade Name
- AEROCHAMBER PLUS FLOW-VU EUDAMED
- Device Name
- AEROCHAMBER PLUS* FLOW-VU* Anti-statisk ventileret kammer – Ungdom - 5+ år Antistaattinen venttiilillinen tilanjatke – Nuori - 5+ vuotta EUDAMED
- Model / Reference
- 108509 EUDAMED108509/108509109060 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00762860509788 EUDAMED
- Basic UDI-DI
- B-00762860509788 EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Pulmonary function analysis system, adult
Aerochamber Plus Flow-Vu by Trudell Medical International — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-00762860509788 | Class I | Active |
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Manufacturer
- Manufacturer
- Trudell Medical International
- EUDAMED SRN
- CA-MF-000009860
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 01616ad0-1ef1-45aa-a27a-49802504a96d 61 fields · synced May 23, 2026