Tracey Technologies
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000027372
- Devices
- 1
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA establishment
Catalogue
- Regimes: CE MDR Registry: EUDAMEDGUDID
Company details
- EUDAMED SRN
- US-MF-000027372
- EUDAMED status
- Active
- EUDAMED registered name
- Tracey Technologies
- EUDAMED abbreviated name
- Tracey
- Registered address
- 16720, Hedgecroft, 77060, Houston, United States
- Website
- traceytechnologies.com
- [email protected]
- Phone
- 1-281-445-1666
- PRRC contact
- Jouana Harris-Livings
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 21 Jan 2030
SGS Belgium NV 1639 1 certificate
- US25/00000029 Active
Quality management system EU MDR
- Issued
- 24 Feb 2026
- Expires
- 21 Jan 2030
- Reason
- Other
FDA establishments
- Tracey Technologies, Corp. HOUSTON, TX · US FEI 1000489825
From the company website
iTrace is a ray-tracing technology used to understand patient’s vision. Enhance your optometry practice and improve vision treatment with Tracey Technologies.
Frequently asked questions
How many devices does Tracey Technologies have in the registry?
The registry currently lists 1 device for Tracey Technologies. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tracey Technologies's devices?
Among its 1 most recently registered device, Tracey Technologies has devices listed in EUDAMED (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Tracey Technologies's devices fall under?
Among its 1 most recently registered device, the classes recorded for Tracey Technologies's devices are Class I. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Tracey Technologies?
EUDAMED lists 1 certificate for Tracey Technologies (quality management system) under MDR. The most recent was issued on 24 Feb 2026.
What are the newest devices from Tracey Technologies in the registry?
The most recently registered devices listed for Tracey Technologies include Tracey-VFA Visual Function Analyzer iTrace.
Which FDA establishments are linked to Tracey Technologies?
1 FDA establishment is linked to Tracey Technologies in the registry; they are listed on the company page.