Arcoma Ab

FDA Filings

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

SWEDEN

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ARCOMA

DUNS 356774109

FDA Registration(s)

• Registration Number: 9616014
• FEI Number: 3002675731
• Name: ARCOMA AB
• Owner & Operator: ARCOMA AB
• Contact Address: ANNAVAGEN 1 --; VAXJO SE-NOTA SE-325 46 SE
• US Agent:
  • Daniel Kamm
  • Kamm & Associates
  • 239 4171727
  • fda.help.now@gmail.com
• Importing Logistics Registration:
  • Importer: FUJIFILM CORPORATION
  • Address: 798 miyanodai kaisei-machi ; ashigarakami-gun, 258-8538 JAPAN
  • Subdivision: JP-13
• Importing Logistics Registration:
  • Importer: KONICA MINOLTA MEDICAL & GRAPHIC, INC.
  • Address: no. 1 Sakura-machi, hino-shi ; Tokyo, 191-8511 JAPAN
  • Phone: 81 42 5898429
  • FAX: 81 42 5898053
  • Subdivision: JP-13
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: ANNAVAGEN 1 ; VAXJO Kronobergs lan [SE-07], S-352 46 SE
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 07350008750098 Arcoma AB	OMNERA 500A	2022-04-07
GUDID 07350008750050 Arcoma AB	RadPRO OMNERA 400T	2018-03-29
GUDID 07350008750012 Arcoma AB	RadPRO OMNERA 400A	2018-03-29
PMN K140683 | MQB ARCOMA AB	Omnera 400 T	2014-06-10
PMN K140683 | MQB ARCOMA AB	Omnera 400 A	2014-06-10
PMN K140683 | MQB ARCOMA AB	DelftDI Triathlon DR	2014-06-10
PMN K140683 | KPR ARCOMA AB	Omnera 400 T	2014-06-10
PMN K140683 | KPR ARCOMA AB	Omnera 400 A	2014-06-10
PMN K140683 | KPR ARCOMA AB	DelftDI Triathlon DR	2014-06-10
PMN K140683 ARCOMA AB	0180 INTUITION, 0072 PRECISION	2014-06-03
PMN K113855 | MQB ARCOMA AB	IMIX PANORAD SL	2013-11-27
PMN K113855 | LLZ ARCOMA AB	IMIX PANORAD SL	2013-11-27
PMN K113855 | KPR ARCOMA AB	IMIX PANORAD SL	2013-11-27
PMN K101435 | KPR ARCOMA AB	IMIX SOMARAD	2013-11-27
PMN K101435 | KPR ARCOMA AB	IMIX PANORAD	2013-11-27
PMN K073114 | KPR ARCOMA AB	IMIX INSIGHT X-RAY SYSTEM	2013-11-27
PMN K072867 | KPR ARCOMA AB	IMIX 2000 IMAGE SYSTEM	2013-11-27
PMN K073632 | KPR ARCOMA AB	Intuition	2008-11-24
PMN K073632 ARCOMA AB	INTUITION, MODEL 0170	2008-01-10
IXR ARCOMA AB	0047-T Elite and Precision Imaging Table	2007-02-26
IXR ARCOMA AB	0047-CV Vascular Imaging Table	2007-02-26
IXR ARCOMA AB	0047-BT Urology table	2007-02-26
IZZ ARCOMA AB	ARCO TABLE NT	1999-08-10
IXY ARCOMA AB	ARCOCOMB	1999-01-26
IYB ARCOMA AB	ARCOCEIL	1998-12-24

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202008138548	Puerto Manzanillo,Panama -> Port Everglades, Florida	X-RAY EQUIPMENT	7 PKG
2020081114724	Puerto Manzanillo,Panama -> Port Everglades, Florida	X-RAY EQUIPMENT	7 PKG
2020073128665	Puerto Manzanillo,Panama -> Baltimore, Maryland	X-RAY EQUIPMENT	7 PKG
2020072115129	Manzanillo,Mexico -> Port Everglades, Florida	X-RAY EQUIPMENT	14 PKG
2020072037104	Puerto Manzanillo,Panama -> Baltimore, Maryland	X-RAY EQUIPMENT	7 PKG
202006308714	Manzanillo,Mexico -> Port Everglades, Florida	X-RAY EQUIPMENT	6 PKG
202006226024	Bremerhaven,Federal Republic of Germany -> Port Everglades, Florida	X-RAY EQUIPMENT	19 PKG
202006226024	Bremerhaven,Federal Republic of Germany -> Port Everglades, Florida	X-RAY PARTS	19 PKG
2020060625586	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	X-RAY EQUIPMENT	19 PKG
2020060625586	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	X-RAY PARTS	19 PKG