Identity
- Trade Name
- iSpiro Ultrasonic Sensor EUDAMEDFDA UDIiSpiro EUDAMED
- Generic Name
- Diagnostic spirometer, professional FDA UDI
- Device Name
- iSpiro Ultrasonic Sensor EUDAMEDiSpiro App EUDAMEDDiagnostic spirometer for measurement and data collection of lung function parameters. FDA UDI
- Model / Reference
- 707115 EUDAMED1524xx EUDAMEDiSpiro Ultrasonic Sensor FDA UDI
- Description
- Diagnostic spirometer for measurement and data collection of lung function parameters. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04057155000795 EUDAMEDFDA UDI04057155000658 EUDAMED
- Basic UDI-DI
- 4057155Z12150101004C9 EUDAMED4057155Z12159082001KE EUDAMED
- Direct Marketing DI
- 04057155000795 EUDAMED
- 510(k) Number
- K213754 FDA UDI
- FDA Product Code
- BZG FDA UDI
- EMDN Code
- Z12150101 CLINICAL/DIAGNOSTIC SPIROMETERS EUDAMEDZ12159082 VARIOUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Diagnostic spirometer, professional FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1840 FDA UDI
- Special Device Type
- Software EUDAMED
- 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
Yes
FDA UDI
MR Unsafe FDA UDI
iSpiro Ultrasonic Sensor 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 | 4057155Z12150101004C9 | 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 (3)
- EUDAMED 0ff0cba4-e786-42c1-b7fa-2931f6f6a3d6 61 fields · synced Jul 17, 2026
- EUDAMED ae2a6330-f823-4f6a-bcd8-1b39a036920a 61 fields · synced May 18, 2026
- FDA UDI 5c02daae-0bc4-4527-b199-60714f24a373 35 fields · synced May 30, 2026