Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681862

FEI Number

1000581837

Entity Name

MEDICEL AG

City/State/Country

Altenrhein Sankt Gallen, CH

Establishment Address

Dornierstrasse 11, Altenrhein Sankt Gallen CH-9423, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MEDICEL AG (Owner Number: 9027853)

Owner / Operator Contact Address

Dornierstrasse 11, --, Altenrhein, CH-SG 9423, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Viscoject 2.2 Viscoject 1.8 211026 EyeGility Inserter for Preloaded enVista IOLs (2) 211027 EyeGility Inserter for Preloaded enVista IOLs (2.4) VIS100 SimplifEYE for enVista Preloaded SimplifEYE inserter for Akreos preloaded ACCUJECT Injector Set 2.1-1P ACCUJECT Injector Set 2.2-1P SMS120 SMS125 SMS125P SMS155P SMS165P SBS110A SMS165 SMS115 SMS170P SMS130 SMS160P SMS135P SMS175P SMS135 SMS370P SMS430 SBS105 SMS410 SMS355P SMS335 SMS325P SMS390S SBS123A SBS310A MCS4523P SBS320A MBSCR23 MCS4521ST MCS4521P MBSCR21 MCS6520T 3032-23 MCS4520P I/A Bimanual Handpiece Set Sophi - 21G I/A Coaxial Handpiece Set Sophi - 21G/45° I/A Coaxial Handpiece Set Sophi - 20G/45° I/A Coaxial Handpiece Set Sophi - 23G/45° I/A Coaxial Handpiece Set Sophi - 21G/45° Soft-Tip BIT23A I/A Bimanual Handpiece Set Sophi -21G/Aeroplane I/A Coaxial Handpiece Set Sophi - 20G/65° I/A Bimanual Handpiece Set Sophi - 23G BIT21A SimplifEYE inserter for enVista Preloaded BLIS-X1

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYB	Lens, Guide, Intraocular	Ophthalmic	Class 1	886.4300	2007-11-20
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2025-03-17
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2014-02-06
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2013-12-02
KYB	Lens, Guide, Intraocular	Ophthalmic	Class 1	886.4300	2019-06-28
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2025-09-23
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	1996-09-16
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2019-11-15
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2014-02-06

Official Correspondent

Michael Enzinger

US Agent Details

Peter Chen Business: Volk Optical Inc. Email: peter.chen@volk.com Phone: (440) 9426161

Related Public Records

Same Entity

MEDICEL AG

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K823222	American Medical Optics	INTRAOCULAR LENS GUIDE	1982-12-28
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0835-2025	Alcon Research LLC	1	Brand Name: Alcon Product Name: Monarch III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch III D delivery cartridge Lens Guide, Intraocular Component: N/A
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.

Similar Registrations

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1650907	Isomedix Operations Inc.	GRAND PRAIRIE, TX, US
9680271	MEDSORB DOMINICANA, S.A.	SAN PEDRO DE MACORIS, DO
1313525	Bausch & Lomb Incorporated	Rochester, NY, US
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 9681862. Last updated year: 2026. Please use registration number 9681862 when referencing this establishment in official correspondence.