Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008269146

FEI Number

3008269146

Entity Name

SFS Group Schweiz AG, KUNSTSTOFFWERK

City/State/Country

Altstaetten Sankt Gallen, CH

Establishment Address

Schoentalstrasse 2 a, Altstaetten Sankt Gallen CH-9450, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

SFS Group Schweiz AG, Kunststoffwerk (Owner Number: 10039591)

Owner / Operator Contact Address

Schoentalstrasse 2 a, Altstaetten, CH-SG CH-9450, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OptraGate Dry Control

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2025-11-28

Official Correspondent

Pascal Hutter

US Agent Details

Steven Lee Business: Tegra Medical Email: slee@tegramedical.com Phone: (508) 5414296

Related Public Records

Same Entity

SFS Group Schweiz AG, Kunststoffwerk

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
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04

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1123010	TRINITY STERILE, INC.	SALISBURY, MD, US
3016789258	EG-MEDACYS DEVICES(SHENZHEN)CO.,LTD	SHENZHEN Guangdong, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008269146. Last updated year: 2026. Please use registration number 3008269146 when referencing this establishment in official correspondence.