Erad, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000018514 FEI 3003150833
Erad, Inc. is a medical device manufacturer based in the United States, with 10 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class II and I) as of 13 Nov 2026.
- Devices
- 10
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 7
- FDA 510(k) 3
- EUDAMED 2
- Device classes
- FDA Class II 9
- FDA Class I 1
- Identifiers
- EUDAMED SRN US-MF-000018514
- FDA FEI 3003150833
- DUNS 023594885
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
Catalogue
- Registry: GUDID
- Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID
- Regimes: 510(k) Registry: GUDID
- Regimes: 510(k) Registry: GUDID
- Registry: GUDID
- Regimes: 510(k) Registry: GUDID
- Regimes: 510(k) Registry: GUDID
- Regimes: CE MDR 510(k) Registry: EUDAMED510(k)
eRAD PACS Ref K241223
Regimes: 510(k) Registry: 510(k)Erad Pacs Ref K061421
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- US-MF-000018514
- FDA FEI number
- 3003150833
- DUNS number
- 023594885
- EUDAMED status
- Active
- EUDAMED registered name
- eRAD, Inc.
- EUDAMED abbreviated name
- eRAD
- Registered address
- 201, Brookfield Pkwy, 29607, Greenville, United States
- Website
- www.erad.com
- Phone
- 866-414-3723
- PRRC contact
- James Connors
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 28 Feb 2030
DNV Product Assurance AS 2460 1 certificate
- C586616 Active
Quality management system EU MDR
- Issued
- 25 Feb 2025
- Expires
- 28 Feb 2030
- Valid from
- 28 Feb 2025
Frequently asked questions
How many devices does Erad, Inc. have in the registry?
The registry currently lists 10 devices for Erad, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Erad, Inc.'s devices?
Among its 10 most recently registered devices, Erad, Inc. has devices listed in EUDAMED (2 devices), FDA 510(k) (3 devices) and FDA GUDID (7 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Erad, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Erad, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Erad, Inc.?
EUDAMED lists 1 certificate for Erad, Inc. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 25 Feb 2025.
What are the newest devices from Erad, Inc. in the registry?
The most recently registered devices listed for Erad, Inc. include eRAD RIS 4.22, eRAD PACS Evolution 8.0, eRAD RIS 3.18 and eRAD PACS 7.3.