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Germany·DE-MF-000008015
Last updated September 17, 2026
About
Clario is a leading provider of clinical trial endpoint data solutions — spanning cardiac safety, eCOA, medical imaging, respiratory, precision motion, and clinical adjudication — serving pharmaceutical, biotech, and CRO customers across every phase of drug development. Clario integrates endpoint data from devices, sites, and patients, enabling customers to digitally collect, manage, and analyze clinical evidence, with its platform supporting approximately 70% of FDA and EMA novel drug approvals over the past decade. Founded in 1999 as eResearchTechnology (ERT), Clario employs approximately 4,000 people globally. Thermo Fisher Scientific (NYSE: TMO) completed its acquisition of Clario on March 24, 2026, for $8.875 billion in cash plus potential additional earnout payments. Clario now operates as part of Thermo Fisher's Laboratory Products and Biopharma Services segment.
From the manufacturer's own website. Source
Information
- Country
- Germany
- Address
- 3, Sieboldstrasse, Estenfeld, Germany
- Website
- www.clario.com
- linkedin.com/company/clario-inc
- —
- [email protected]
- Phone
- +49 9 305 720 9891
- PRRC Contact
- Kadir Tayyip Taşlıca
- EUDAMED SRN
- DE-MF-000008015
- FDA FEI Number
- 3008505660
- DUNS Number
- —
Catalogue (33)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Am3 | 1414xx | EUDAMEDFDA UDI | Class IIa | Active |
| MasterScope WSSU / MasterScope ECG | 171611 | EUDAMEDFDA UDI | Class IIa | Active |
| SpiroSphere, SpiroSphereECG, CardioSphere | K223629 | FDA 510(k) | Class II | Active |
| MasterScope CT / MasterScope ECG | 171601 | EUDAMEDFDA UDI | Class IIa | Active |
| SpiroSphere ECG | 151261 | EUDAMEDFDA UDI | Class IIa | Active |
| SpiroSphere ECG | 151221 | EUDAMEDFDA UDI | Class IIa | Active |
| MasterScope WSSU | 171610 | EUDAMEDFDA UDI | Class IIa | Active |
| Rotationsflowgeber | 1413xx | EUDAMEDFDA UDI | Class IIa | Active |
| SpiroSphere ECG | 151311, 151314 | EUDAMEDFDA UDI | Class IIa | Active |
| Am3 | 1414xx | EUDAMEDFDA UDI | Class IIa | Active |
| SpiroSphere Sensor | 707410, 151210 | EUDAMEDFDA UDI | Class IIa | Active |
| SpiroSphere | 151313 | EUDAMEDFDA UDI | Class IIa | Active |
| Ert Pt | 706000 | EUDAMEDFDA UDI | Class IIa | Active |
| Amos | 1511xx | EUDAMEDFDA UDI | Class IIa | Active |
| Pneumotach | 709554 | EUDAMEDFDA UDI | Class IIa | Active |
| MasterScope | 171400, 171410 | EUDAMEDFDA UDI | Class IIa | Active |
| SpiroSphere | 151310 | EUDAMEDFDA UDI | Class IIa | Active |
| SpiroSphere | 151200 | EUDAMEDFDA UDI | Class IIa | Active |
| SpiroSphere | 707407 | EUDAMEDFDA UDI | Class IIa | Active |
| SpiroSphere | 151260 | EUDAMEDFDA UDI | Class IIa | Active |
| CardioSphere | 151312, 151315 | EUDAMEDFDA UDI | Class IIa | Active |
| iSpiro Ultrasonic Sensor | 707115 | EUDAMEDFDA UDI | Class IIa | Active |
| Ert Pt | 706000 | EUDAMEDFDA UDI | Class IIa | Active |
| Pneumotach | 709555 | EUDAMEDFDA UDI | Class IIa | Active |
| SpiroWay | 892114 | EUDAMEDFDA UDI | Class IIa | Active |
| MasterScope ECG | 993125 | EUDAMEDFDA UDI | Class IIa | Active |
| SpiroSphere | 151250 | EUDAMEDFDA UDI | Class IIa | Active |
| MasterScope CT | 171600 | EUDAMEDFDA UDI | Class IIa | Active |
| MasterScope | 1714xx + 993125 | EUDAMEDFDA UDI | Class IIa | Active |
| SpiroSphere | 151220 | EUDAMEDFDA UDI | Class IIa | Active |
| SpiroSphere | 707406 | EUDAMEDFDA UDI | Class IIa | Active |
| MasterScope CT | 706235 | EUDAMEDFDA UDI | Class IIa | Active |
| MasterScope WSSU | 707419 | EUDAMEDFDA UDI | Class IIa | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- eResearchTechnology, Inc. Philadelphia, PA · US FEI 1000103389