Lojer Oy

FDA Filings

This page includes the latest FDA filings for Lojer Oy. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3009307605
• FEI Number: 3009307605
• Name: Robert Ballantine
• Owner & Operator: Lojer Oy
• Contact Address: Putajantie 42 ; Sastamala FI-LS Lansi-Suomen laani FIN-38210 FI
• US Agent:
  • Robert Ballantine
  • ELvation Medical
  • 770 2950049
  • 678 4176273
  • robert.ballantine@elvation.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2220 Northmont Parkway ; Duluth, GA 30096 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 06430021930668 Lojer Oy	Manuthera 242 Manuthera 242	2022-12-08
GUDID 06430021930576 Lojer Oy	Capre FX5 Capre FX5	2022-12-08
GUDID 06430021930569 Lojer Oy	Capre FX3 Capre FX3	2022-12-08
GUDID 06430021930538 Lojer Oy	Capre F5 AM Capre F5 AM	2022-12-08
GUDID 06430021930521 Lojer Oy	Capre F5 Capre F5	2022-12-08
GUDID 06430021930514 Lojer Oy	Capre F3 Capre F3	2022-12-08
GUDID 06430021930507 Lojer Oy	Capre F2 Capre F2	2022-12-08
GUDID 06430021930477 Lojer Oy	Capre M4 AM Capre M4 AM	2022-12-08
GUDID 06430021930460 Lojer Oy	Capre M4 Capre M4	2022-12-08
GUDID 06430021930453 Lojer Oy	Capre M2 Capre M2	2022-12-08
INQ Robert Ballantine [Lojer Oy]	Lojer Manuthera 242	2017-01-16
INQ Robert Ballantine [Lojer Oy]	Lojer Capre M Treatment Table	2017-01-16
INQ Robert Ballantine [Lojer Oy]	Lojer Capre FX Treatment Table	2017-01-16
INQ Robert Ballantine [Lojer Oy]	Lojer Capre F Treatment Table	2017-01-16

Related Finance Registrations

NCAGE Code	A072G	LOJER OY
CAGE Code	A072G	LOJER OY

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
201904055247	Anvers,Belgium -> Savannah, Georgia	HOSPITAL EQUIPMENT, HS 940290 PHYSICAL EXCER .	8 CAS
201902149155	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	CAPRE 5 SEXTION TREATMENT TABLE	2 PKG
2019020913291	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	CAPRE 5 SEXTION TREATMENT TABLE	2 PKG
2019020715688	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	CAPRE 5 SEXTION TREATMENT TABLE	2 PKG
2019020613029	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	CAPRE 5 SEXTION TREATMENT TABLE	2 PKG
2019020223522	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	CAPRE 5 SEXTION TREATMENT TABLE	2 PKG
2019013135568	Anvers,Belgium -> New York, New York	CAPRE 5 SEXTION TREATMENT TABLE	2 PKG
2019012636700	Anvers,Belgium -> New York, New York	CAPRE 5 SEXTION TREATMENT TABLE	2 PKG