Identity
- Trade Name
- Aerobika EUDAMED
- Device Name
- Aerobika* Oscillating Positive Expiratory Pressure Device EUDAMED
- Model / Reference
- 110501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00762860100022 EUDAMED
- Basic UDI-DI
- 762860OPEP1G4 EUDAMED
- 510(k) Number
- K150173 FDA 510(k)
- FDA Product Code
- BWF FDA 510(k)
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5690 FDA 510(k)
- Regulation Number
- 868.5690 FDA 510(k)
- Market of Registration
- Türkiye EUDAMED
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Pulmonary function analysis system, adult
Aerobika by Trudell Medical International — Class I — MDD, FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 762860OPEP1G4 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K150173 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 762860OPEP1G4 | 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 efe8a6f0-c490-4c5d-959d-86c6a954cb36 61 fields · synced Jul 28, 2026
- FDA 510(k) K150173 24 fields · synced May 18, 2026