EDDA Technology, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000050953 FEI 3004857110
EDDA Technology, Inc. is a medical device manufacturer based in the United States, with 10 devices listed in FDA 510(k), FDA GUDID and EUDAMED (FDA Class II) as of 14 Nov 2026.
- Devices
- 10
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA 510(k) 5
- FDA GUDID 5
- EUDAMED 1
- Device classes
- FDA Class II 10
- Identifiers
- EUDAMED SRN US-MF-000050953
- FDA FEI 3004857110
- DUNS 782779701
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
What EDDA Technology, Inc. makes
EDDA Technology, Inc. develops software applications for processing and analyzing DICOM medical images, including tools for quality assurance and diagnostic support in radiology. Their portfolio includes specialized software packages for liver and chest imaging, designed to enhance multimodality analysis and improve workflow efficiency in clinical settings.
The company’s products are classified as Class II medical devices under FDA regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. EDDA Technology, Inc. is headquartered in the United States.
Catalogue
- Regimes: 510(k) Registry: GUDID
- Regimes: 510(k) Registry: GUDID
- Regimes: 510(k) Registry: GUDID
- Regimes: 510(k) Registry: GUDID
- Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID
Iqqa-Liver Software Ref K061696
Regimes: 510(k) Registry: 510(k)Iqqa-Bodyimaging Software Ref K141745
Regimes: 510(k) Registry: 510(k)Iqqa-Chest Software Package Ref K042408
Regimes: 510(k) Registry: 510(k)Iqqa-Liver Multimodality Software Ref K131498
Regimes: 510(k) Registry: 510(k)IQQA Guide Ref K151414
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- US-MF-000050953
- FDA FEI number
- 3004857110
- DUNS number
- 782779701
- EUDAMED status
- Active
- EUDAMED registered name
- EDDA Technology, Inc.
- Registered address
- 5, Independence Way, 08540, Princeton, United States
- Phone
- 1-609-919-9889
- PRRC contact
- Xiaolan Zeng
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 16 Dec 2030
TÜV Rheinland LGA Products GmbH 0197 1 certificate
- HZ 2213011-1 Active
Quality management system EU MDR
- Issued
- 11 Jun 2026
- Expires
- 16 Dec 2030
- Reason
- Other
Frequently asked questions
How many devices does EDDA Technology, Inc. have in the registry?
The registry currently lists 10 devices for EDDA Technology, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list EDDA Technology, Inc.'s devices?
Among its 10 most recently registered devices, EDDA Technology, Inc. has devices listed in EUDAMED (1 device), FDA 510(k) (5 devices) and FDA GUDID (5 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do EDDA Technology, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for EDDA Technology, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for EDDA Technology, Inc.?
EUDAMED lists 1 certificate for EDDA Technology, Inc. (quality management system) under MDR. The most recent was issued on 11 Jun 2026.
What are the newest devices from EDDA Technology, Inc. in the registry?
The most recently registered devices listed for EDDA Technology, Inc. include EDDA TECHNOLOGY IQQA-Liver Multimodality, EDDA TECHNOLOGY IQQA-Chest, EDDA TECHNOLOGY IQQA-Liver and EDDA TECHNOLOGY IQQA-Guide.