EXCEL-LENS, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000032977 FEI 3030860039
- Devices
- 5
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
CAPSULBlue Ref CAPSULBlue Syringe
Regimes: CE MDD Registry: EUDAMEDCAPSULaser Cataract System Ref 178-0295
Regimes: CE MDD Registry: EUDAMEDCAPSULaser Cataract System Ref 178-0262
Regimes: CE MDD Registry: EUDAMEDCAPSULaser Cataract System Ref 178-0297
Regimes: CE MDD Registry: EUDAMEDCAPSULBlue Ref 178-0025
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- US-MF-000032977
- SRN (system / procedure pack)
- US-PR-000035332
- FDA FEI number
- 3030860039
- EU VAT number
- 46-3894583
- EUDAMED status
- Active
- EUDAMED registered name
- EXCEL-LENS, Inc.
- EUDAMED abbreviated name
- EXCEL
- Registered address
- 2316, Orchard Parkway, 95377, Tracy, United States
- Website
- www.capsulaser.com
- linkedin.com/company/capsulaser
- [email protected]
- PRRC contact
- Gladys Copeland
From the company website
EXCEL-LENS, Inc. is a ISO 13485:2016 certified developer and manufacturer of medical devices and its facility is registered with the U.S. FDA.
Frequently asked questions
How many devices does EXCEL-LENS, Inc. have in the registry?
The registry currently lists 5 devices for EXCEL-LENS, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list EXCEL-LENS, Inc.'s devices?
Among its 5 most recently registered devices, EXCEL-LENS, Inc. has devices listed in EUDAMED (5 devices).
What risk classes do EXCEL-LENS, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for EXCEL-LENS, Inc.'s devices are Class IIa and Class IIb. Each device page shows its own class and authorisation.
What are the newest devices from EXCEL-LENS, Inc. in the registry?
The most recently registered devices listed for EXCEL-LENS, Inc. include CAPSULBlue and CAPSULaser Cataract System.