Gestenco I N T Ab

FDA Filings

This page includes the latest FDA filings for Gestenco I N T Ab. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3004109528
• FEI Number: 3004109528
• Name: GESTENCO INTERNATIONAL AB
• Owner & Operator: GESTENCO INTERNATIONAL AB
• Contact Address: 14 FRIDKULLAGATAN --; GOTEBORG SE-NOTA SE 400 22 SE
• Official Correspondent:
  • GORAN - STEEN
  • 46-31-810035-x
• US Agent:
  • Elisa Maldonado-Holmertz
  • Obelix Consulting, LLC
  • 512 4316069
  • elisamh@obelixconsult.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: FRIDKULLAGATAN 14 ; GOTEBORG Vastra Gotalands lan [SE-14], SE 412 62 SE
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 07333117000179 Gestenco International AB	Lip Retractor LR-00-02	2020-10-23
GUDID 07333117000162 Gestenco International AB	Lip Retractor LR-00-01	2020-10-23
GUDID 07333117000148 Gestenco International AB	Cheek retractor CR-00-01	2020-10-23
GUDID 07333117000063 Gestenco International AB	SmartBond LC SM-300-LC	2020-10-23
GUDID 07333117000056 Gestenco International AB	SmartBond LC SM-100-LC	2020-10-23
GUDID 07333117000049 Gestenco International AB	SmartBond SM-001	2020-10-23
GUDID 07333117000032 Gestenco International AB	SmartBond SM-002	2020-10-23
GUDID 07333117000223 Gestenco International AB	Freddy FCB-00-01HK	2020-10-22
GUDID 07333117000087 Gestenco International AB	Freddy FCB-00-01	2020-10-22
GUDID 07333117000216 Gestenco International AB	Springtime KITSP-55-55HKS	2018-07-06
GUDID 07333117000070 Gestenco International AB	Bite-Bumper BB-00-01	2018-07-06
GUDID 07333117000025 Gestenco International AB	SmartBond SM-010	2018-07-06
GUDID 07333117000018 Gestenco International AB	SmartBond SM-000	2018-07-06
EIF GESTENCO INTERNATIONAL AB	Orthodontic ruler	2013-01-23
BRW GESTENCO INTERNATIONAL AB	Lip Retractor	2010-12-07
BRW GESTENCO INTERNATIONAL AB	Evacu	2010-12-07
BRW GESTENCO INTERNATIONAL AB	Cheek Retractor	2010-12-07
PMN K981036 | DYH GESTENCO INTERNATIONAL AB	SmartBond	2007-12-05
PMN K053055 | DYW GESTENCO INTERNATIONAL AB	Solo	2007-12-05
PMN K053055 | DYW GESTENCO INTERNATIONAL AB	Phantom	2007-12-05
PMN K053055 | DYW GESTENCO INTERNATIONAL AB	Oyster	2007-12-05
PMN K053055 | DYW GESTENCO INTERNATIONAL AB	Image	2007-12-05
PMN K053055 | DYW GESTENCO INTERNATIONAL AB	Blonde	2007-12-05
PMN K053055 | DYW GESTENCO INTERNATIONAL AB	Bite-Bumper	2007-12-05
PMN K053055 GESTENCO INTERNATIONAL AB	ORTHODONTIC POLYMER COMPOSITE BRACKET	2005-12-22