Identity
- Trade Name
- AMOS EUDAMEDAsthma Monitor AMOS app FDA UDI
- Generic Name
- Expiratory peak flow meter, digital FDA UDI
- Device Name
- Asthma Monitor EUDAMEDAccessory to ERT's Asthma Monitor device for professional users FDA UDI
- Model / Reference
- AM3 EUDAMED1511xx EUDAMED2.x FDA UDI
- Description
- Accessory to ERT's Asthma Monitor device for professional users FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04057155000603 EUDAMEDFDA UDI
- Basic UDI-DI
- 4057155Z12150102001CA EUDAMED
- 510(k) Number
- K183479 FDA UDI
- FDA Product Code
- BZG FDA UDI
- EMDN Code
- Z12150102 PEAK FLOW SPIROMETERS EUDAMED
- GMDN Term
- Expiratory peak flow meter, digital FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1840 FDA UDI
- Market of Registration
- Germany 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
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
Prescription Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Amos by eResearchTechnology GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4057155Z12150102001CA | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- eResearchTechnology GmbH
- EUDAMED SRN
- DE-MF-000008015
Sources (2)
- EUDAMED 68ba4c0a-3e26-4565-9ac3-bea2b4387273 61 fields · synced Jul 24, 2026
- FDA UDI 121eb1f2-ea8e-4fe3-a6cc-bb95f84c645a 35 fields · synced May 29, 2026