Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615659

FEI Number

3003289411

Entity Name

MORIA S.A.

City/State/Country

MASSY Hauts-de-Seine, FR

Establishment Address

23 Avenue Carnot, 3 Rue Christophe Colomb, MASSY Hauts-de-Seine 91300, FR

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Moria S.A. (Owner Number: 9029102)

Owner / Operator Contact Address

23 Avenue Carnot, 3 Rue Christophe Colomb, MASSY, FR-92 91300, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K040297

PMA Number

N/A

All Registered Proprietary Names

20047_HOFFART HOOK 20046_TANITO HOOK 205_SILASTIC METER REF. 205 Microsurgical, instruments tray ST-T1 Microsurgical, instruments tray ST-L1 Microsurgical, instruments tray ST-S1

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HMY	Keratome, Battery-Powered	Ophthalmic	Class 1	886.4370	2008-11-12
HNO	Keratome, Ac-Powered	Ophthalmic	Class 1	886.4370	2008-01-17
HNX	Depressor, Orbital	Ophthalmic	Class 1	886.4350	2007-10-18
HMY	Keratome, Battery-Powered	Ophthalmic	Class 1	886.4370	2008-11-12
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	1997-01-10
HNH	Ring, Ophthalmic (Flieringa)	Ophthalmic	Class 1	886.4350	1997-01-10
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	1997-01-10
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	1997-01-10
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	1997-01-10
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	1997-01-10
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2019-03-26
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2017-12-06
HNO	Keratome, Ac-Powered	Ophthalmic	Class 1	886.4370	2008-01-17
HNO	Keratome, Ac-Powered	Ophthalmic	Class 1	886.4370	2008-11-12
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	1997-01-10
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	1997-01-10
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	1997-01-10
HNZ	Curette, Ophthalmic	Ophthalmic	Class 1	886.4350	1997-01-10
JYQ	Loop, Wire	Ear, Nose, Throat	Class 1	874.4420	1997-01-10
HNJ	Punch, Corneo-Scleral	Ophthalmic	Class 1	886.4350	2006-10-18
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	1997-01-10
HMY	Keratome, Battery-Powered	Ophthalmic	Class 1	886.4370	2008-11-12
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	1997-01-10
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	1997-01-10
HMY	Keratome, Battery-Powered	Ophthalmic	Class 1	886.4370	2008-01-17

Official Correspondent

No official correspondent registered.

US Agent Details

James Kusters Business: Moria, Inc. Email: jkusters@moriausa.com Phone: (215) 2307662

Related Public Records

Same Entity

Moria S.A.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3016214537	Metal Process	Montevrain Ile-de-France, FR
3011659857	Ophsurin Co., Ltd	Suqian Jiangsu, CN
3000264417	Moria S.A	Bourbon l'Archambault Allier, FR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30
K905383	Micro Surgical Instruments Corp.	2710-000 OSCILLATING SAW, GENERAL ASSEMBLY	1991-06-18
K913369	Micro Surgical Instruments Corp.	MICRO-AIRE MODEL 2060	1991-11-01
K871646	Ocular Instruments, Inc.	TANNE CORNEAL CUTTING BLOCK	1987-05-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.

Similar Registrations

Registration Number	Establishment Name	Location
2246552	Isomedix Operations Inc.	S Plainfield, NJ, US
3000264417	Moria S.A	Bourbon l'Archambault Allier, FR
3010383847	STERISERVICES	Bernay Eure, FR
3016214537	Metal Process	Montevrain Ile-de-France, FR
3005012805	MIDWEST STERILIZATION CORP.	LAREDO, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615659. Last updated year: 2026. Please use registration number 9615659 when referencing this establishment in official correspondence.