GE Parallel Design, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000009295 FEI 3003309342
GE Parallel Design, Inc. is a medical device manufacturer based in the United States, with 23 devices listed in FDA GUDID and EUDAMED (FDA Class II; EU Class IIa) as of 13 Nov 2026.
- Devices
- 23
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 23
- EUDAMED 3
- Device classes
- FDA Class II 20
- EU Class IIa 3
- Top EMDN categories
- Sites and related companies
- GE Medical Systems SCS authorised representative
- Identifiers
- EUDAMED SRN US-MF-000009295
- FDA FEI 3003309342
- DUNS 623906971
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
- Authorised rep.
- GE Medical Systems SCSFR
What GE Parallel Design, Inc. makes
GE Parallel Design, Inc. manufactures hand-held extracorporeal ultrasound imaging transducers designed for portable diagnostic imaging. These devices are intended for real-time visualization of internal body structures, supporting clinical assessments in various medical settings.
The company’s portfolio consists of Class IIa medical devices, which are regulated under the EU Medical Device Regulation (MDR) framework. These devices are listed in the EU’s eudamed registry, ensuring traceability and compliance with European Union requirements. The manufacturer is based in the United States.
Catalogue
Search and filter all 23 devicesCompany details
- EUDAMED SRN
- US-MF-000009295
- FDA FEI number
- 3003309342
- DUNS number
- 623906971
- EUDAMED status
- Active
- EUDAMED registered name
- GE Parallel Design, Inc.
- Registered address
- 4313, Cotton Center Blvd, 85040, Phoenix, United States
- Phone
- +1(800)437-1171
- PRRC contact
- Bryan Behn
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 7 Feb 2028
TÜV Rheinland LGA Products GmbH 0197 1 certificate
- HZ 2238876-1 Active
Quality management system EU MDR
- Issued
- 8 Feb 2023
- Expires
- 7 Feb 2028
Frequently asked questions
How many devices does GE Parallel Design, Inc. have in the registry?
The registry currently lists 23 devices for GE Parallel Design, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list GE Parallel Design, Inc.'s devices?
Among its 23 most recently registered devices, GE Parallel Design, Inc. has devices listed in EUDAMED (3 devices) and FDA GUDID (23 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do GE Parallel Design, Inc.'s devices fall under?
Among its 23 most recently registered devices, the classes recorded for GE Parallel Design, Inc.'s devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for GE Parallel Design, Inc.?
EUDAMED lists 1 certificate for GE Parallel Design, Inc. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 8 Feb 2023.
What are the newest devices from GE Parallel Design, Inc. in the registry?
The most recently registered devices listed for GE Parallel Design, Inc. include 4C, 4C-D, 8L-RS and i12L-RS.