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SpiroSphere
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 151200Ref 151300Ref 707400Ref 707405
Identity
- Trade Name
- SpiroSphere EUDAMEDFDA UDI
- Generic Name
- Diagnostic spirometer, professional FDA UDI
- Device Name
- SpiroSphere EUDAMEDMain Unit of diagnostic spirometer for measurement and data collection of lung function parameters FDA UDIDiagnostic spirometer for measurement and data collection of lung function parameters FDA UDI
- Model / Reference
- 151200 EUDAMED151300 EUDAMED707400 EUDAMED707405 EUDAMEDSpiroSphere Main Unit FDA UDISpiroSphere FDA UDISpiroSphere CT FDA UDI
- Description
- Main Unit of diagnostic spirometer for measurement and data collection of lung function parameters FDA UDIDiagnostic spirometer for measurement and data collection of lung function parameters FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04057155000535 EUDAMEDFDA UDI04057155000351 EUDAMEDFDA UDI04057155000528 EUDAMEDFDA UDI04057155000719 EUDAMEDFDA UDI
- Basic UDI-DI
- 4057155Z12150101003C7 EUDAMED
- Direct Marketing DI
- 04057155000351 EUDAMED04057155000719 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
No
FDA UDIFDA 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 (8)
- EUDAMED f882cc4d-b154-493f-8f59-4650787719a5 61 fields · synced Jul 30, 2026
- FDA UDI ecf6f842-5397-4d30-9a0a-0426b13d7b71 35 fields · synced May 29, 2026
- FDA UDI dde8db62-9a59-4698-9974-badc6c071305 35 fields · synced May 30, 2026
- FDA UDI e63f38ca-b573-4edd-9d7d-ff19842f93d3 35 fields · synced May 30, 2026
- FDA UDI 33d245ef-2f3b-48a3-84ed-0c4f35c61243 35 fields · synced May 30, 2026
- EUDAMED f714324a-98c1-4c31-acf6-2f6002c31ca1 61 fields · synced Jul 9, 2026
- EUDAMED 544620b6-1a62-43e5-a636-269dc3bb60e4 61 fields · synced Jul 22, 2026
- EUDAMED da35411a-668b-4b3c-9170-3666c7455df3 61 fields · synced Jul 30, 2026