Teratech Corporation
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000033295 FEI 3002315840
Teratech Corporation is a medical device manufacturer based in the United States, with 46 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class II; EU Class IIa) as of 15 Nov 2026.
- Devices
- 46
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 24
- FDA 510(k) 19
- EUDAMED 15
- Device classes
- FDA Class II 32
- EU Class IIa 14
- Top EMDN categories
- Sites and related companies
- Wellkang Ltd authorised representative
- Identifiers
- EUDAMED SRN US-MF-000033295
- FDA FEI 3002315840
- DUNS 836416321
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
- Authorised rep.
- Wellkang LtdXI
What Teratech Corporation makes
Teratech Corporation manufactures handheld ultrasound imaging systems designed for body-surface scans, including multi-transducer connection units for expanded imaging flexibility. The company also produces foetal Doppler probes and rectal/vaginal ultrasound transducers, which are used for targeted internal imaging. These devices are branded under the Terason line.
The company’s products are regulated as Class II and Class IIa medical devices, with listings in the EU’s eudamed registry and the US FDA’s 510(k) and UDI databases. Teratech Corporation is headquartered in the United States.
Catalogue
Search and filter all 46 devicesCompany details
- EUDAMED SRN
- US-MF-000033295
- FDA FEI number
- 3002315840
- DUNS number
- 836416321
- EUDAMED status
- Active
- EUDAMED registered name
- Teratech Corporation
- EUDAMED abbreviated name
- Teratech
- Registered address
- 77-79, Terrace Hall Ave, 01803, Burlington, United States
- Website
- www.terason.com
- Phone
- 7812704143
- PRRC contact
- Steven Broadstone
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 1 Mar 2031
Intertek Medical Notified Body AB 2862 1 certificate
- 28620253687 Active
Quality management system EU MDR
- Issued
- 13 Aug 2026
- Expires
- 1 Mar 2031
Frequently asked questions
How many devices does Teratech Corporation have in the registry?
The registry currently lists 46 devices for Teratech Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Teratech Corporation's devices?
Among its 46 most recently registered devices, Teratech Corporation has devices listed in EUDAMED (15 devices), FDA 510(k) (19 devices) and FDA GUDID (24 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Teratech Corporation's devices fall under?
Among its 46 most recently registered devices, the classes recorded for Teratech Corporation's devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Teratech Corporation?
EUDAMED lists 1 certificate for Teratech Corporation (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 13 Aug 2026.
What are the newest devices from Teratech Corporation in the registry?
The most recently registered devices listed for Teratech Corporation include Terason uSmart3200T, Terason uSmart3300 Cart, Terason PDOF and Terason uSmart3200T Roller Bag.