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AeroChamber Plus* FlowVu*
EUDAMEDClass I (EU MDR)
Ref 108507/10850783070Ref 108502/108502110070
Identity
- Trade Name
- AeroChamber Plus* FlowVu* EUDAMED
- Device Name
- Valved Holding Chamber EUDAMED
- Model / Reference
- 108507/10850783070 EUDAMED108502/108502110070 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00762860013544 EUDAMED00762860013513 EUDAMED
- Basic UDI-DI
- 762860VHC1NL EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece EUDAMEDAustria EUDAMED
Clinical & Handling
Sterile
No
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Pulmonary function analysis system, adult
AeroChamber Plus* FlowVu* by Trudell Medical International — 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 | 762860VHC1NL | 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 (2)
- EUDAMED 451baaec-13c2-4287-bc68-2ff8983c9c31 61 fields · synced Jun 20, 2026
- EUDAMED 82936555-ef33-4f1d-9325-de3e242daea9 61 fields · synced May 18, 2026