Identity
- Trade Name
- CardioSphere EUDAMEDSpiroSphere FDA UDI
- Generic Name
- Electrocardiograph, professional, multichannel FDA UDI
- Device Name
- SpiroSphere EUDAMEDDiagnostic device for ECG measurement and data collection FDA UDI
- Model / Reference
- 151312, 151315 EUDAMED151262 EUDAMEDCardioSphere CT FDA UDICardioSphere Standard FDA UDI
- Description
- Diagnostic device for ECG measurement and data collection FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04057155000672 EUDAMEDFDA UDI04057155000696 EUDAMEDFDA UDI
- Basic UDI-DI
- 4057155Z12150101003C7 EUDAMED
- 510(k) Number
- K223629 FDA UDI
- FDA Product Code
- DPS FDA UDI
- EMDN Code
- C020599 CARDIAC DIAGNOSTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Electrocardiograph, professional, multichannel FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2340 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
CardioSphere 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 (5)
- EUDAMED 9a3c27a1-f4f0-42c3-a6b7-09bba8f882d1 61 fields · synced Jul 15, 2026
- EUDAMED b326888f-43c1-4504-a8f3-8aea5c3b9f00 61 fields · synced May 18, 2026
- FDA UDI 147d94a1-a48d-4320-a24c-54fb89070bb7 35 fields · synced May 27, 2026
- FDA UDI a67b593e-e6b0-4e59-8725-dcbb6a907aaa 35 fields · synced May 30, 2026
- EUDAMED 9a3c27a1-f4f0-42c3-a6b7-09bba8f882d1-1 61 fields · synced Jul 9, 2026