Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8031050

FEI Number

3788

Entity Name

JOTA AG

City/State/Country

RUETHI, SG Sankt Gallen, CH

Establishment Address

Hirschensprungstrasse 2, RUETHI, SG Sankt Gallen 9464, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Jota AG (Owner Number: 8031050)

Owner / Operator Contact Address

Hirschensprungstrasse 2, Ruethi, CH-SG CH-9464, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

JOTA JOTA JOTA JOTA JOTA JOTA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTT	Burr, Orthopedic	Orthopedic	Class 1	888.4540	2003-10-22
EHL	Point, Abrasive	Dental	Class 1	872.6010	2003-10-22
EKD	Instrument, Cutting, Operative	Dental	Class 1	872.4565	2003-10-22
EHJ	Disk, Abrasive	Dental	Class 1	872.6010	2003-10-22
EJQ	Wheel, Polishing Agent	Dental	Class 1	872.6010	2003-10-22
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2003-10-22

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Jota AG

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8031050. Last updated year: 2026. Please use registration number 8031050 when referencing this establishment in official correspondence.