Identity
- Trade Name
- MasterScope WSSU / MasterScope ECG EUDAMEDMasterScope FDA UDI
- Generic Name
- Diagnostic spirometer, professional FDA UDI
- Device Name
- MasterScope EUDAMEDdiagnostic spirometer for measurement and data collection of lung function parameters with option ECG FDA UDI
- Model / Reference
- 171611 EUDAMEDMasterScope WSSU with 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
- 04057155000641 EUDAMEDFDA UDI
- Basic UDI-DI
- 4057155Z12150101001C3 EUDAMED
- 510(k) Number
- K202754 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
MasterScope WSSU / MasterScope 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 | 4057155Z12150101001C3 | 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 c64fd4ed-e00a-4f42-a702-e752436d6573 61 fields · synced Jun 19, 2026
- FDA UDI 7541edbd-213b-4b19-8571-91acb9d30fdc 35 fields · synced May 30, 2026