SIGVARIS AG

FDA Device Registration & Listing · ST GALLEN Sankt Gallen, CH · Registration 8031005

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
8031005
FEI Number
5929
Entity Name
SIGVARIS AG
City/State/Country
ST GALLEN Sankt Gallen, CH
Establishment Address
GROEBLISTRASSE 8, ST GALLEN Sankt Gallen 9014, CH
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Sigvaris Holding AG (Owner Number: 8031005)
Owner / Operator Contact Address
Sandgrube 29, Appenzell, CH-AI 9050, CH
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IKX Aid, Transfer Physical Medicine Class 1 890.5050 2025-01-13
FQL Stocking, Medical Support (For General Medical Purposes) General Hospital Class 1 880.5780 2001-11-05

Official Correspondent

No official correspondent registered.

US Agent Details

Robert Brooks Business: Sigvaris Inc. Email: robert.brooks@sigvaris.com Phone: (770) 6322950

Related Public Records

Same Entity

Sigvaris Holding AG
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3004903147 Sigvaris Do Brasil Ind. E Com. LTDA Jundiai Sao Paulo, BR
1221770 SIGVARIS, INC. PEACHTREE CITY, GA, US
3009591331 SIGVARIS France S.A.S. Saint-Just, Saint-Rambert Auvergne-Rhone-Alpes, FR
3005550595 SIGVARIS Inc. - Holland Facility Holland, MI, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8031005. Last updated year: 2026. Please use registration number 8031005 when referencing this establishment in official correspondence.
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