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Aerobika
EUDAMEDFDA UDIClass I (EU MDR)
Ref 110501 110502/11050491010Model 110501/110502
Identity
- Trade Name
- Aerobika EUDAMEDAEROBIKA OPEP Manometer FDA UDI
- Generic Name
- Positive pressure airway secretion-clearing device FDA UDI
- Device Name
- Aerobika* Oscillating Positive Expiratory Pressure Device with Manometer Accessory EUDAMEDAEROBIKA OPEP Manometer FDA UDI
- Model / Reference
- 110501/110502 EUDAMED110501 110502/11050491010 EUDAMED110502 FDA UDI
- Description
- AEROBIKA OPEP Manometer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00762860105027 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00762860105027 EUDAMED
- 510(k) Number
- K150173 FDA UDI
- FDA Product Code
- BWF FDA UDI
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
- GMDN Term
- Positive pressure airway secretion-clearing device FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5690 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pulmonary function analysis system, adult
Aerobika by Trudell Medical International — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00762860105027 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 e81f22c8-7919-4320-b3c3-ae8ef729a887 61 fields · synced Jul 25, 2026
- FDA UDI 3bf0201b-99e5-4643-9a48-de0330a38dac 35 fields · synced May 30, 2026