Identity
- Trade Name
- Rotationsflowgeber EUDAMEDFDA UDI
- Generic Name
- Expiratory peak flow meter, digital FDA UDI
- Device Name
- Asthma Monitor EUDAMEDRotary flow sensor for single-patient use, accessory to Asthma Monitor FDA UDI
- Model / Reference
- AM3 EUDAMED1413xx EUDAMEDRotationsflowgeber FDA UDI
- Description
- Rotary flow sensor for single-patient use, accessory to Asthma Monitor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04057155000337 EUDAMEDFDA UDI
- Basic UDI-DI
- 4057155Z12150102001CA EUDAMED
- 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Expiratory peak flow meter, digital
Rotationsflowgeber by eResearchTechnology GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Expiratory peak flow meter, digital.
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- NxGen Peak Flow Meter — SAFEY MEDICAL DEVICES PRIVATE LIMITED · Class II
- Spirosound — Medset Medizintechnik GmbH · Class IIa
- Model 4000 — Vitalograph Ireland, Ltd. · Class II
- Model 4000 — Vitalograph Ireland, Ltd. · Class II
- Model 4000 — Vitalograph Ireland, Ltd. · Class II
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 b24bb8e5-002a-47cd-bbea-d3530d580233 61 fields · synced Jun 19, 2026
- FDA UDI d8c7fce8-711c-497d-a065-b713697fa420 35 fields · synced May 30, 2026