Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710128

FEI Number

3002541228

Entity Name

ANTONI CARLES, S.A.

City/State/Country

VILASSAR DE MAR Barcelona, ES

Establishment Address

POL. IND. "ELS GARROFERS", Volta dels Garrofers, 41-42, VILASSAR DE MAR Barcelona 08340, ES

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ANTONI CARLES, S.A. (Owner Number: 9045051)

Owner / Operator Contact Address

Pol. Ind. "Els Garrofers", Volta dels Garrofers, 41-42, Vilassar de Mar, ES-B 08340, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IS-600N IS-1D IS-100 CGS-1000 ATE-S GR880 GR840 CGS-1000 ATE-300

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HMF	Stand, Instrument, Ac-Powered, Ophthalmic	Ophthalmic	Class 1	886.1860	2001-03-12
HRJ	Table, Instrument, Powered, Ophthalmic	Ophthalmic	Class 1	886.4855	2001-03-12

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

ANTONI CARLES, S.A.

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3004784203	TOWA MEDICAL INSTRUMENTS CO.,LTD.	Nakano-shi Nagano, JP
2031508	TPC ADVANCED TECHNOLOGY, INC.	City Industry, CA, US
3005785090	TAIZHOU CITY K&W INTERNATIONAL TRADE CO.,LTD.	Jiangyan Jiangsu, CN
3011898560	BEIJING HONGDEE CORPORATION	Beijing, CN
3011689956	DYLAN LUCAS INTERNATIONAL INC	Vaughan Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710128. Last updated year: 2026. Please use registration number 9710128 when referencing this establishment in official correspondence.