Identity
- Trade Name
- SpiroSphere ECG EUDAMEDSpiroSphere FDA UDI
- Generic Name
- Diagnostic spirometer, professional FDA UDI
- Device Name
- SpiroSphere EUDAMEDDiagnostic spirometer for measurement and data collection of lung function parameters with option ECG FDA UDI
- Model / Reference
- 151221 EUDAMEDSpiroSphere ECG FDA UDI
- Description
- Diagnostic spirometer for measurement and data collection of lung function parameters with option ECG FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04057155000580 EUDAMEDFDA UDI
- Basic UDI-DI
- 4057155Z12150101003C7 EUDAMED
- 510(k) Number
- K223629 FDA UDI
- FDA Product Code
- BTY FDA UDIDPS FDA UDI
- EMDN Code
- C020599,Z12150101 EUDAMED
- GMDN Term
- Diagnostic spirometer, professional FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1890 FDA UDI870.2340 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
Yes
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
SpiroSphere ECG 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 | 4057155Z12150101003C7 | 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 5c8a8007-1a24-411d-b6f9-916d82f7a0c1 61 fields · synced Jul 31, 2026
- FDA UDI 0a2103d9-5048-45ff-a6ca-9ad7518f7e91 35 fields · synced May 30, 2026