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Home›USA›X-Cel Contacts, Inc.

X-Cel Contacts, Inc.

USA · Erie
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
6listed device types
Class I 0Class II 3Class III 2unclassified 1
plus 50 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
8active device licences
Class II 8
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States50 registration records, 4 510(k), 0 PMA, 2 excluded
Brazil1 confirmed, 0 excluded
Canada8 confirmed, 0 excluded
Manufacturer names merged into this page: X-CEL SPECIALTY CONTACTS
Same-named companies — This database also contains companies with near-identical names: X-CEL SPECIALTY CONTACTS. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Erie

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12003 · K030593
12007 · K070308
12010 · K100443
12024 · K242059

FDA listed device types

Lens, Contact (Other Material) - Daily 1Lens, Contact (Orthokeratology) 1Lenses, Soft Contact, Daily Wear 1Lens, Contact (Polymethylmethacrylate) 1Lens, Contact (Rigid Gas Permeable), Extended Wear 1Lens, Contact, Orthokeratology, Overnight 1

Registration details (sample)

MarketIdentifierNameClass / date
USK242059Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)2024-08-14
USK100443DEFINITIVE, FLEXLENS - SILICONE HYDROGEL2010-10-28
USK070308FLEXLENS MULTIFOCAL SOFT CONTACT LENS, (HIOXIFILCON A) AND (HIOXIFILCON B) FOR DAILY WEAR2007-03-12
BR80222129002LENTES DE CONTATO FERRARA ESCLERALClass II
CA25379EXTREME H2O SOFT CONTACT LENSClass II
CA79077EXTREME H2O SOFT CONTACT LENSClass II
CA94594FLEXLENS (LUCIFILCON A) WESTCON HORIZON (LUCIFILCON A) SOFT CONTACT LENSESClass II

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