Home › United States › Ortho-Clinical Diagnostics, Inc. Rochester
Manufacturer of medical devices registered in the European database in Rochester, United States.
| Registration number (SRN) | US-MF-000009352 |
|---|---|
| Short name | Ortho Rochester |
| Role | Manufacturer |
| Status | Active |
| Country | United States |
| City | 14626 Rochester |
| Address | Indigo Creek Drive, 100 14626 Rochester |
| Registered on | 2021-07-08 |
| FDA establishment register | Similar name in the FDA register — unverified |
|---|---|
| Matched entry | Ortho-Clinical Diagnostics (GB) · FDA 3007111389 |
⚠️ A similar name exists. We do not assert it is the same company — a name alone is not proof. This one needs a human check.
| Certificate | Status | Expiry | Type | Body |
|---|---|---|---|---|
V12 093358 0003 | supplemented | 2027-07-04 | Quality management system | NB 0123 |
⚠️ State of the register on 2026-08-20. EUDAMED shows only the current version of a certificate — earlier versions are not published, by the Commission or by anyone. A certificate shown as valid here may have changed since. For a legally binding check, consult EUDAMED directly.
The SRN is the registration number assigned by the European Commission. It has been mandatory since 28 May 2026 for any operator placing a medical device on the Union market. Contact details are published in the official register; we do not reproduce them here.
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