Anatomage, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000027423 FEI 3008272529
Anatomage, Inc. is a medical device manufacturer based in the United States, with 12 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II; EU Class IIa) as of 13 Nov 2026.
- Devices
- 12
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 10
- EUDAMED 4
- FDA 510(k) 2
- Device classes
- FDA Class II 8
- EU Class IIa 4
- Top EMDN categories
- Sites and related companies
- Freyr Regulatory GmbH authorised representative
- Identifiers
- EUDAMED SRN US-MF-000027423
- FDA FEI 3008272529
- DUNS 962613332
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
- Authorised rep.
- Freyr Regulatory GmbHDE
What Anatomage, Inc. makes
Anatomage, Inc. manufactures radiology information system application software, including products such as InvivoLight, TxStudio, Anatomage Table, InvivoMac, InvivoDental ROW, InVivoDental, CephSimulation, Collage, Invivo Workspace Web Viewer, and Table.
The company's devices are classified as Class II and Class IIa and are listed in regulatory registries including Eudamed, FDA 510(k), and FDA UDI. Anatomage, Inc. is based in the United States.
Catalogue
Search and filter all 12 devicesCompany details
- EUDAMED SRN
- US-MF-000027423
- FDA FEI number
- 3008272529
- DUNS number
- 962613332
- EUDAMED status
- Active
- EUDAMED registered name
- Anatomage, Inc.
- Registered address
- 3350, Scott Blvd., 95054, Santa Clara, United States
- Phone
- +1 (408)333-3484
- PRRC contact
- Tim Nguyen
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 20 Oct 2029
BSI Group The Netherlands B.V. 2797 1 certificate
- MDR 758993 Active
Quality management system EU MDR
- Issued
- 25 Jun 2026
- Expires
- 20 Oct 2029
- Reason
- Other
Frequently asked questions
How many devices does ANATOMAGE, INC. have in the registry?
The registry currently lists 12 devices for ANATOMAGE, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list ANATOMAGE, INC.'s devices?
Among its 12 most recently registered devices, ANATOMAGE, INC. has devices listed in EUDAMED (4 devices), FDA 510(k) (2 devices) and FDA GUDID (10 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do ANATOMAGE, INC.'s devices fall under?
Among its 12 most recently registered devices, the classes recorded for ANATOMAGE, INC.'s devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for ANATOMAGE, INC.?
EUDAMED lists 1 certificate for ANATOMAGE, INC. (quality management system) under MDR. The most recent was issued on 25 Jun 2026.
What are the newest devices from ANATOMAGE, INC. in the registry?
The most recently registered devices listed for ANATOMAGE, INC. include InvivoLight 6.0, TxStudio 6.0, Anatomage Table 5.0.1 and TxStudio 7.0.