Identity
- Trade Name
- SpiroSphere EUDAMEDFDA UDI
- Generic Name
- Diagnostic spirometer, professional FDA UDI
- Device Name
- SpiroSphere EUDAMEDDiagnostic spirometer for measurement and data collection of lung function parameters FDA UDI
- Model / Reference
- 151220 EUDAMEDSpiroSphere FDA UDI
- Description
- Diagnostic spirometer for measurement and data collection of lung function parameters FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04057155000757 EUDAMEDFDA UDI
- Basic UDI-DI
- 4057155Z12150101003C7 EUDAMED
- 510(k) Number
- K173937 FDA UDI
- FDA Product Code
- BTY FDA UDI
- EMDN Code
- Z12150101 CLINICAL/DIAGNOSTIC SPIROMETERS EUDAMED
- GMDN Term
- Diagnostic spirometer, professional FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1890 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 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 20b153ed-29c9-46ad-925f-2b0b62edce38 61 fields · synced Jul 26, 2026
- FDA UDI 652f642e-6f17-4b4b-a103-23c976c220ac 35 fields · synced May 29, 2026