Identity
- Trade Name
- AM3 EUDAMEDAsthma Monitor AM3 FDA UDI
- Generic Name
- Expiratory peak flow meter, digital FDA UDI
- Device Name
- Asthma Monitor EUDAMEDAsthma Monitor, electronic peak flow meter with TCP/IP FDA UDI
- Model / Reference
- AM3 EUDAMED1414xx EUDAMEDAM3 G+ FDA UDI
- Description
- Asthma Monitor, electronic peak flow meter with TCP/IP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04057155000207 EUDAMEDFDA UDI
- Basic UDI-DI
- 4057155Z12150102001CA EUDAMED
- Direct Marketing DI
- 04057155000207 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Am3 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 32829a6f-cf2d-4b8a-b9e5-d4db07e37f96 61 fields · synced Jun 18, 2026
- FDA UDI 896a87cb-8905-4c9d-87fa-b43686489d43 35 fields · synced May 30, 2026