Ortho-Clinical Diagnostics, Inc. Rochester
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000009352
- Devices
- 3
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
Catalogue
VITROS Chemistry Products Calibrator Kit 35 Ref 6811213
Regimes: CE IVDR Registry: EUDAMEDVITROS Chemistry Products ALBp Slides Ref 6112233
Regimes: CE IVDR Registry: EUDAMEDVITROS Chemistry Products ALBp Slides Ref 6811212
Regimes: CE IVDR Registry: EUDAMED
Company details
- EUDAMED SRN
- US-MF-000009352
- EUDAMED status
- Active
- EUDAMED registered name
- Ortho-Clinical Diagnostics, Inc. Rochester
- EUDAMED abbreviated name
- Ortho Rochester
- Registered address
- 100, Indigo Creek Drive, 14626, Rochester, United States
- Website
- quidelortho.com
- linkedin.com/company/quidelortho
- facebook.com/QuidelOrtho
- [email protected]
- Phone
- +1 858 552 1100
- PRRC contact
- Jon Waxmonsky
EUDAMED certificates
1 certificate1 valid, 0 expiredIVDR 1next expiry 4 Jul 2027
TÜV SÜD Product Service GmbH 0123 1 certificate
- V12 093358 0003 Expiring
Quality management system EU IVDR
- Issued
- 7 Aug 2026
- Expires
- 4 Jul 2027
- Reason
- Add device or group
From the company website
We invite you to connect with us and explore how our diagnostic portfolio can make a difference in your healthcare setting. Together, we can work toward a healthier future by leveraging advanced diagnostics to improve patient care, safety and treatment decisions.
Frequently asked questions
How many devices does Ortho-Clinical Diagnostics, Inc. Rochester have in the registry?
The registry currently lists 3 devices for Ortho-Clinical Diagnostics, Inc. Rochester. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ortho-Clinical Diagnostics, Inc. Rochester's devices?
Among its 3 most recently registered devices, Ortho-Clinical Diagnostics, Inc. Rochester has devices listed in EUDAMED (3 devices).
What risk classes do Ortho-Clinical Diagnostics, Inc. Rochester's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Ortho-Clinical Diagnostics, Inc. Rochester's devices are IVDR Class B. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Ortho-Clinical Diagnostics, Inc. Rochester?
EUDAMED lists 1 certificate for Ortho-Clinical Diagnostics, Inc. Rochester (quality management system) under IVDR. The most recent was issued on 7 Aug 2026.
What are the newest devices from Ortho-Clinical Diagnostics, Inc. Rochester in the registry?
The most recently registered devices listed for Ortho-Clinical Diagnostics, Inc. Rochester include VITROS Chemistry Products Calibrator Kit 35 and VITROS Chemistry Products ALBp Slides.