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Data / Medical devices / France / Moria S.A.

Moria S.A.: FDA-registered device maker in MASSY Hauts-de-Seine, France, 10 510(k) clearances

Moria S.A. is registered with the FDA (registration 9615659) in MASSY Hauts-de-Seine, France. It lists 24 device types. The FDA files 10 510(k) clearances under its listings, the newest dated October 26, 2017. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
9615659
FEI number
3003289411
Address
23 Avenue Carnot 3 Rue Christophe Colomb, MASSY Hauts-de-Seine, France, 91300
Owner or operator
Moria S.A. (9029102)
Roles
Specification developer
First device listed
January 10, 1997
Registered through
2026
Brand names listed
20046_TANITO HOOK, 20047_HOFFART HOOK, 205_SILASTIC METER REF. 205, Microsurgical, instruments tray ST-L1, Microsurgical, instruments tray ST-S1, Microsurgical, instruments tray ST-T1

Devices it lists

DeviceProduct codeClassRoleSource
Caliper, OphthalmicHOE1Specification developeraccessdata.fda.gov
Cannula, OphthalmicHMX1Specification developeraccessdata.fda.gov
Curette, OphthalmicHNZ1Specification developeraccessdata.fda.gov
Depressor, OrbitalHNX1Specification developeraccessdata.fda.gov
Forceps, OphthalmicHNR1Specification developeraccessdata.fda.gov
Handle, ScalpelGDZ1Specification developeraccessdata.fda.gov
Hook, OphthalmicHNQ1Specification developeraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Specification developeraccessdata.fda.gov
Instrument, MicrosurgicalGZX1Specification developeraccessdata.fda.gov
Keratome, Ac-PoweredHNO1Specification developeraccessdata.fda.gov
Keratome, Battery-PoweredHMY1Specification developeraccessdata.fda.gov
Knife, OphthalmicHNN1Specification developeraccessdata.fda.gov
Loop, WireJYQ1Specification developeraccessdata.fda.gov
Marker, OcularHMR1Specification developeraccessdata.fda.gov
Motor, Surgical Instrument, Ac-PoweredGEY1Specification developeraccessdata.fda.gov
Needle, Ophthalmic SuturingHNM1Specification developeraccessdata.fda.gov
Probe, LachrymalHNL1Specification developeraccessdata.fda.gov
Punch, Corneo-ScleralHNJ1Specification developeraccessdata.fda.gov
Retractor, OphthalmicHNI1Specification developeraccessdata.fda.gov
Ring, Ophthalmic (Flieringa)HNH1Specification developeraccessdata.fda.gov
Scissors, OphthalmicHNF1Specification developeraccessdata.fda.gov
Spatula, OphthalmicHND1Specification developeraccessdata.fda.gov
Specula, OphthalmicHNC1Specification developeraccessdata.fda.gov
Trephine, Manual, OphthalmicHRH1Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 26, 2017K172994EPI K ConsoleHNOSubstantially EquivalentMoria SAaccessdata.fda.gov
March 25, 2005K043183EPI-KHNOSubstantially EquivalentMoria SAaccessdata.fda.gov
June 18, 2004K032836M3 MICROKERATOMEHNOSubstantially EquivalentMoria SAaccessdata.fda.gov
March 31, 2004K040297ONEUSE- PLUS MICROKERATOMEHMYSubstantially EquivalentMoria SAaccessdata.fda.gov
September 27, 2002K022560M2 SINGLE USE MICROKERTOMEHMYSubstantially EquivalentMoria SAaccessdata.fda.gov
March 9, 2001K003594CARRIAZO BARRAQUER SINGLE USE MICROKERATOMEHMYSubstantially EquivalentMoria, Inc.accessdata.fda.gov
October 12, 2000K002191CARRIAZO BARRAQUER II MICROKERATOMEHMYSubstantially EquivalentMoria, Inc.accessdata.fda.gov
August 25, 1998K981742ONE UP DISPOSABLE KERATOME HEADHNOSubstantially EquivalentMoria, Inc.accessdata.fda.gov
July 24, 1998K981741CARRIAZO BARRAQUER MICROKERATOMEHMYSubstantially EquivalentMoria, Inc.accessdata.fda.gov
March 31, 1997K970377PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES)HNOSubstantially EquivalentPlancon Instrumentsaccessdata.fda.gov

Compare with other makers

Updated October 26, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.