Lumithera, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000029866 FEI 3016232028
- Devices
- 3
- Registrations
- EUDAMEDFDA
- FDA recalls
- 11 ongoing
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI, FDA recalls
Catalogue
Valeda LumiKey Ref 300003
Regimes: CE MDR Registry: EUDAMEDValeda Light Delivery System Ref 200001-03
Regimes: CE MDD Registry: EUDAMEDValeda Light Delivery System Ref DEN230083
Regimes: De Novo Registry: De NovoGUDID
Company details
- EUDAMED SRN
- US-MF-000029866
- FDA FEI number
- 3016232028
- DUNS number
- 030100076
- EUDAMED status
- Active
- EUDAMED registered name
- LumiThera, Inc.
- Registered address
- 6201, South Freeway, 76134, Fort Worth, United States
- Website
- www.lumithera.com
- [email protected]
- Phone
- +44 2 076 60 1516
- PRRC contact
- Lori Holder
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 18 Aug 2031
BSI Group The Netherlands B.V. 2797 1 certificate
- MDR 788091 Active
Quality management system EU MDR
- Issued
- 19 Aug 2026
- Expires
- 18 Aug 2031
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 1
- 2026 0
2025
- 7 May 2025 Z-2046-2025 Class III Ongoing U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet.
Frequently asked questions
How many devices does Lumithera, Inc. have in the registry?
The registry currently lists 3 devices for Lumithera, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Lumithera, Inc.'s devices?
Among its 3 most recently registered devices, Lumithera, Inc. has devices listed in EUDAMED (2 devices), FDA 510(k) (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 Lumithera, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Lumithera, Inc.'s devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Lumithera, Inc.?
FDA recall records list 1 recall initiated by Lumithera, Inc., the most recent initiated on 7 May 2025. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for Lumithera, Inc.?
EUDAMED lists 1 certificate for Lumithera, Inc. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 19 Aug 2026.
What are the newest devices from Lumithera, Inc. in the registry?
The most recently registered devices listed for Lumithera, Inc. include Valeda LumiKey and Valeda Light Delivery System.