Cenova Ab

FDA Filings

This page includes the latest FDA filings for Cenova 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: 3005216725
• FEI Number: 3005216725
• Name: CENOVA AB
• Owner & Operator: CENOVA AB
• Contact Address: 4, FLORETTGATAN --; MJOLBY SE-NOTA 595 43 SE
• Official Correspondent:
  • Jonas - Hjertstedt
  • 46-142-55812-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: 4, FLORETTGATAN ; MJOLBY Ostergotlands lan [SE-05], 595 43 SE
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K193268 | KNW CENOVA AB	AprioCore plus	2020-03-13
PMN K182116 | MAH CENOVA AB	BAHA	2019-11-05
PMN K181756 | FCG CENOVA AB	Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle	2019-01-02
PMN K150555 | MAH CENOVA AB	BAHA	2017-08-23
PMN K121317 | MAH CENOVA AB	BAHA	2017-08-23
PMN K152067 | MAH CENOVA AB	Ponto bone anchored hearing system	2016-09-19
PMN K142678 | MAH CENOVA AB	Ponto bone anchored hearing system	2016-09-19
PMN K121228 | MAH CENOVA AB	Ponto bone anchored hearing system	2016-09-19
PMN K112053 | MAH CENOVA AB	Ponto bone anchored hearing system	2016-09-19
PMN K040143 | DZE CENOVA AB	ANEW, Atlas	2016-09-16
PMN K082108 | LXB CENOVA AB	Ponto bone anchored hearing system	2014-12-19
PMN K080355 | HAW CENOVA AB	Disposable Inserts, Item nr: 912464	2014-02-21
PMN K992872 | LXB CENOVA AB	BA210 abutment 8.5mm for flange fixture	2013-01-16
PMN K992872 | LXB CENOVA AB	BA210 abutment 5.5mm for flange fixture	2013-01-16
PMN K992872 | LXB CENOVA AB	Abutment snap coupling 8.5mm	2013-01-16
PMN K992872 | LXB CENOVA AB	Abutment snap coupling 5,5mm	2013-01-16
PMN K955713 | LXB CENOVA AB	Healing cap with plug ?30mm	2013-01-16
PMN K955713 | LXB CENOVA AB	Healing cap with plug ?20mm	2013-01-16
PMN K955713 | LXB CENOVA AB	Cover screw space w internal hexagon	2013-01-16
PMN K955713 | LXB CENOVA AB	Cover screw Unigrip	2013-01-16
PMN K945154 | FZE CENOVA AB	Standard Abutment 7mm	2013-01-16
PMN K945154 | FZE CENOVA AB	Standard Abutment 5,5mm	2013-01-16
PMN K945154 | FZE CENOVA AB	Standard Abutment 4mm	2013-01-16
PMN K945154 | FZE CENOVA AB	Standard Abutment 3mm	2013-01-16
PMN K945154 | FZE CENOVA AB	Healing cap	2013-01-16
PMN K945154 | FZE CENOVA AB	Healing abutment 7mm Unigrip	2013-01-16
PMN K945154 | FZE CENOVA AB	Healing Cap ? 6,5mm	2013-01-16
PMN K945154 | FZE CENOVA AB	Healing Cap ? 14mm	2013-01-16
PMN K945154 | FZE CENOVA AB	Guide drill 3 + 4mm	2013-01-16
PMN K945154 | FZE CENOVA AB	Gold bar ?2 x 50 mm	2013-01-16
PMN K945154 | FZE CENOVA AB	Gold bar ?2 x 100 mm	2013-01-16
PMN K945154 | FZE CENOVA AB	Gold Cylinder 4mm	2013-01-16
PMN K945154 | FZE CENOVA AB	Drill countersink 4mm	2013-01-16
PMN K945154 | FZE CENOVA AB	Drill countersink 3mm	2013-01-16
PMN K945154 | FZE CENOVA AB	Console abutment 90? Unigrip	2013-01-16
PMN K945154 | FZE CENOVA AB	Console abutment 60? Unigrip	2013-01-16
PMN K945154 | FZE CENOVA AB	Console abutment 30? Unigrip	2013-01-16
PMN K945154 | FZE CENOVA AB	Console abutment 110? Unigrip	2013-01-16
PMN K100360 | LXB CENOVA AB	Widening drill 4mm w countersink	2013-01-16
PMN K100360 | LXB CENOVA AB	Widening drill 3mm w countersink	2013-01-16
PMN K100360 | LXB CENOVA AB	Single use kit w Baha blade 4mm FAST	2013-01-16
PMN K100360 | LXB CENOVA AB	Single use kit 4mm FAST	2013-01-16
PMN K100360 | LXB CENOVA AB	Single use instrument kit w Baha blade 4mm FAST	2013-01-16
PMN K100360 | LXB CENOVA AB	Single use instrument kit 4mm FAST	2013-01-16
PMN K100360 | LXB CENOVA AB	Healing cap ?30mm	2013-01-16
PMN K100360 | LXB CENOVA AB	Healing cap ?20mm	2013-01-16
PMN K100360 | LXB CENOVA AB	Guide drill 3 + 4mm	2013-01-16
PMN K100360 | LXB CENOVA AB	Cover screw conical	2013-01-16
PMN K100360 | LXB CENOVA AB	BA300 abutment 9mm	2013-01-16
PMN K100360 | LXB CENOVA AB	BA300 abutment 6mm	2013-01-16
PMN K021837 | LXB CENOVA AB	Flange fixture ST 4mm	2013-01-16
PMN K021837 | LXB CENOVA AB	Flange fixture ST 4mm w. Baha abutment	2013-01-16
PMN K021837 | LXB CENOVA AB	Flange fixture ST 3mm	2013-01-16
PMN K021837 | LXB CENOVA AB	Flange fixture ST 3mm w. Baha abutment	2013-01-16
PMN K021837 | LXB CENOVA AB	Fixture ST 4mm	2013-01-16
PMN K021837 | LXB CENOVA AB	Fixture ST 3mm	2013-01-16
PMN K021837 | LXB CENOVA AB	BIA210 flange fixture ST 4mm w abutment 5.5mm	2013-01-16
PMN K021837 | LXB CENOVA AB	BIA210 flange fixture ST 3mm w abutment 5.5mm	2013-01-16