R82 A S

FDA Filings

This page includes the latest FDA filings for R82 A S. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3001657382
• FEI Number: 3001657382
• Name: R82 A/S
• Owner & Operator: R82 A/S
• Contact Address: Parallelvej 3 --; Gedved DK-NOTA DK-8751 DK
• Official Correspondent:
  • Ulla Lange
  • 45-796-85888-x
• US Agent:
  • Ryan Williams
  • R82 Inc.
  • 310 6180111
  • ryan@convaid.com
• Importing Logistics Registration:
  • Importer: R82 Inc.
  • Address: 12801 E. Independence Blvd ; Matthews, NC 28106 UNITED STATES
  • Importer Type: Agent
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: PARALLELVEJ 3 ; GEDVED Region Midtjylland, DK-8751 DK
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 05715393014019 R82 A/S	R82 870023-RS	2024-09-23
GUDID 05715393014002 R82 A/S	R82 870022-RS	2024-09-23
GUDID 05715393013999 R82 A/S	R82 870011-2RS	2024-09-23
GUDID 05715393013982 R82 A/S	R82 870011-1RS	2024-09-23
GUDID 05707292977946 R82 A/S	R82 881022	2024-08-22
GUDID 05707292977922 R82 A/S	R82 881012	2024-08-22
GUDID 05707292975225 R82 A/S	R82 881121220	2024-08-22
GUDID 05707292975201 R82 A/S	R82 881121210	2024-08-22
GUDID 05707292975188 R82 A/S	R82 881121200	2024-08-22
GUDID 05707292975164 R82 A/S	R82 881121120	2024-08-22
GUDID 05707292975140 R82 A/S	R82 881121110	2024-08-22
GUDID 05707292975126 R82 A/S	R82 881121100	2024-08-22
GUDID 05707292975102 R82 A/S	R82 881111220	2024-08-22
GUDID 05707292975089 R82 A/S	R82 881111210	2024-08-22
GUDID 05707292975065 R82 A/S	R82 881111200	2024-08-22
GUDID 05707292975041 R82 A/S	R82 881111120	2024-08-22
GUDID 05707292975027 R82 A/S	R82 881111110	2024-08-22
GUDID 05707292975003 R82 A/S	R82 881111100	2024-08-22
GUDID 05707292908094 R82 A/S	R82 87064	2023-08-10
GUDID 05707292908087 R82 A/S	R82 87063	2023-08-10
GUDID 05707292908070 R82 A/S	R82 87062	2023-08-10
GUDID 05707292908063 R82 A/S	R82 87061	2023-08-10
GUDID 05707292908056 R82 A/S	R82 87060	2023-08-10
GUDID 05707292578099 R82 A/S	R82 87550	2023-08-10
GUDID 05707292977021 R82 A/S	R82 9001000002001	2023-05-16
GUDID 05707292975775 R82 A/S	R82 9101000011101	2023-05-16
GUDID 05707292975720 R82 A/S	R82 9201002003102	2023-05-16
GUDID 05707292975676 R82 A/S	R82 9621008011111	2023-05-16
GUDID 05707292975669 R82 A/S	R82 9610000003015	2023-05-16
GUDID 05707292975591 R82 A/S	R82 9214002011101	2023-05-16
GUDID 05707292975560 R82 A/S	R82 9417005011107	2023-05-16
GUDID 05707292975515 R82 A/S	R82 9406000003111	2023-05-16
GUDID 05707292975454 R82 A/S	R82 9101000003001	2023-05-16
GUDID 05707292597861 R82 A/S	R82 8711120	2022-10-20
GUDID 05707292591999 R82 A/S	R82 972110210	2022-10-20
GUDID 05707292577672 R82 A/S	R82 860104-ELFP	2022-10-20
GUDID 05707292577658 R82 A/S	R82 860103-ELFP	2022-10-20
GUDID 05707292577634 R82 A/S	R82 860102-ELFP	2022-10-20
GUDID 05707292577627 R82 A/S	R82 860102-FP	2022-10-20
GUDID 05707292577603 R82 A/S	R82 860101-FP	2022-10-20
GUDID 05707292576286 R82 A/S	R82 880505-01	2022-10-20
GUDID 05707292576279 R82 A/S	R82 973110210	2022-10-20
GUDID 05707292573582 R82 A/S	R82 972150210	2022-10-20
GUDID 05707292571793 R82 A/S	R82 973150210	2022-10-20
GUDID 05707292569073 R82 A/S	R82 972141220	2022-10-20
GUDID 05707292567079 R82 A/S	R82 973110110	2022-10-20
GUDID 05707292566232 R82 A/S	R82 972141210	2022-10-20
GUDID 05707292565716 R82 A/S	R82 973110120	2022-10-20
GUDID 05707292565617 R82 A/S	R82 973141220	2022-10-20
GUDID 05707292565228 R82 A/S	R82 869015	2022-10-20
GUDID 05707292565006 R82 A/S	R82 973141210	2022-10-20
GUDID 05707292561848 R82 A/S	R82 973140220	2022-10-20
GUDID 05707292561831 R82 A/S	R82 973140210	2022-10-20
GUDID 05707292561817 R82 A/S	R82 972140210	2022-10-20
GUDID 05707292553317 R82 A/S	R82 89508-1S	2022-10-20
GUDID 05707292553119 R82 A/S	R82 869021	2022-10-20
GUDID 05707292553102 R82 A/S	R82 869011	2022-10-20
GUDID 05707292540072 R82 A/S	R82 89508-1M	2022-10-20
GUDID 05707292538321 R82 A/S	R82 8702222-XP	2022-10-20
GUDID 05707292538314 R82 A/S	R82 8702212-XP	2022-10-20
GUDID 05707292520364 R82 A/S	R82 869020	2022-10-20
GUDID 05707292509390 R82 A/S	R82 8910142-01	2022-10-20
GUDID 05707292505132 R82 A/S	R82 882035	2022-10-20
GUDID 05707292505125 R82 A/S	R82 882034	2022-10-20
GUDID 05707292490698 R82 A/S	R82 8911607-02EL	2022-10-20
GUDID 05707292459855 R82 A/S	R82 8911603-02EL	2022-10-20
GUDID 05707292459848 R82 A/S	R82 8911603-02	2022-10-20
GUDID 05707292459824 R82 A/S	R82 8911613-02	2022-10-20
GUDID 05707292459558 R82 A/S	R82 8911615-02EL	2022-10-20
GUDID 05707292459534 R82 A/S	R82 8911605-02EL	2022-10-20
GUDID 05707292459527 R82 A/S	R82 8911615-02	2022-10-20
GUDID 05707292458858 R82 A/S	R82 8911605-02	2022-10-20
GUDID 05707292450807 R82 A/S	R82 8910132-01	2022-10-20
GUDID 05707292419170 R82 A/S	R82 861004	2022-10-20
GUDID 05707292419163 R82 A/S	R82 861003	2022-10-20
GUDID 05707292419149 R82 A/S	R82 861002	2022-10-20
GUDID 05707292419125 R82 A/S	R82 861001	2022-10-20
GUDID 05707292416704 R82 A/S	R82 882005	2022-10-20
GUDID 05707292394965 R82 A/S	R82 87047	2022-10-20
GUDID 05707292394958 R82 A/S	R82 87046	2022-10-20
GUDID 05707292394644 R82 A/S	R82 87045	2022-10-20
GUDID 05707292386915 R82 A/S	R82 882025	2022-10-20
GUDID 05707292386908 R82 A/S	R82 882024	2022-10-20
GUDID 05707292386878 R82 A/S	R82 882015	2022-10-20
GUDID 05707292386861 R82 A/S	R82 882014	2022-10-20
GUDID 05707292254573 R82 A/S	R82 880204-NL	2022-10-20
GUDID 05707292254566 R82 A/S	R82 880203-NL	2022-10-20
GUDID 05707292254559 R82 A/S	R82 880202-NL	2022-10-20
GUDID 05707292254542 R82 A/S	R82 880201-NL	2022-10-20
GUDID 05707292254399 R82 A/S	R82 88010-3	2022-10-20
GUDID 05707292254382 R82 A/S	R82 88010-2	2022-10-20
GUDID 05707292254375 R82 A/S	R82 88010-1	2022-10-20
GUDID 05707292134202 R82 A/S	R82 880104	2022-10-20
GUDID 05707292134196 R82 A/S	R82 880103	2022-10-20
GUDID 05707292134189 R82 A/S	R82 880102	2022-10-20
GUDID 05707292134172 R82 A/S	R82 880101	2022-10-20
GUDID 05707292130693 R82 A/S	R82 87702	2022-10-20
GUDID 05707292129246 R82 A/S	R82 86402	2022-10-20
GUDID 05707292129239 R82 A/S	R82 86401	2022-10-20
GUDID 05707292129222 R82 A/S	R82 86400	2022-10-20
PMN K151492 | LBE R82 A/S	Kudu	2018-08-06
PMN K151492 | IOR R82 A/S	Kudu	2018-08-06
PMN K100084 | IOR R82 A/S	Multi frame	2018-08-06
PMN K151492 R82 A/S	Kudu	2016-05-20
INM R82 A/S	x:panda	2014-08-12
INM R82 A/S	Wombat Solo	2014-08-12
INM R82 A/S	Wombat Living	2014-08-12
INM R82 A/S	Swan	2014-08-12
INM R82 A/S	Stingray	2014-08-12
INM R82 A/S	Serval	2014-08-12
INM R82 A/S	Panda Futura	2014-08-12
INM R82 A/S	Panda Futura 5	2014-08-12
INM R82 A/S	Heron	2014-08-12
INM R82 A/S	Flamingo	2014-08-12
INM R82 A/S	Flamingo High-Low	2014-08-12
INM R82 A/S	Cricket	2014-08-12
ILS R82 A/S	Penguin	2014-08-12
ILS R82 A/S	Orca	2014-08-12
PMN K100084 R82 A/S	MULTI FRAME WHEELCHAIR	2010-04-12
INQ R82 A/S	Caribou	2009-01-11
INQ R82 A/S	Buffalo	2009-01-11
KNO R82 A/S	Multi Frame	2009-01-09
KNO R82 A/S	Kudu	2009-01-09
KNO R82 A/S	Cougar	2009-01-09
KNN R82 A/S	Multi Frame	2009-01-09
KNN R82 A/S	Kudu	2009-01-09
KNN R82 A/S	Cougar	2009-01-09
ISR R82 A/S	Toucan	2009-01-09
ISR R82 A/S	Rabbit	2009-01-09
IQB R82 A/S	Multi Frame	2009-01-09
IQB R82 A/S	Kudu	2009-01-09
IQB R82 A/S	Cougar	2009-01-09
IMZ R82 A/S	Multi frame	2009-01-09
IMZ R82 A/S	Kudu	2009-01-09
IMZ R82 A/S	Cougar	2009-01-09
IMX R82 A/S	Multi Frame	2009-01-09
IMX R82 A/S	Kudu	2009-01-09
IMX R82 A/S	Cougar	2009-01-09
IMW R82 A/S	Multi Frame	2009-01-09
IMW R82 A/S	Kudu	2009-01-09
IMW R82 A/S	Cougar	2009-01-09
IMS R82 A/S	Multi Frame	2009-01-09
IMS R82 A/S	Kudu	2009-01-09
IMS R82 A/S	Cougar	2009-01-09
IMP R82 A/S	Multi Frame	2009-01-09
IMP R82 A/S	Kudu	2009-01-09
IMP R82 A/S	Cougar	2009-01-09
IMO R82 A/S	Multi Frame	2009-01-09
IMO R82 A/S	Kudu	2009-01-09
IMO R82 A/S	Cougar	2009-01-09
IMM R82 A/S	Multi frame	2009-01-09
IMM R82 A/S	Kudu	2009-01-09
IMM R82 A/S	Cougar	2009-01-09
IML R82 A/S	Multi Frame	2009-01-09
IML R82 A/S	Kudu	2009-01-09
IML R82 A/S	Cougar	2009-01-09
PMN K061810 R82 A/S	COUGAR WHEELCHAIR	2006-08-07
PMN K030882 R82 A/S	RABBIT MOBILE STANDING FRAME	2003-04-04
PMN K061810 | IOR R82 A/S	Cougar	2002-03-09
ITJ R82 A/S	Pony	2002-03-09
ITJ R82 A/S	Mustang	2002-03-09
ITJ R82 A/S	Crocodile	2002-03-09
INW R82 A/S	Toucan	2002-03-09
INW R82 A/S	Rabbit Up	2002-03-09
INW R82 A/S	Meerkat	2002-03-09
INW R82 A/S	Gazelle PS	2002-03-09
INW R82 A/S	Caribou	2002-03-09
INW R82 A/S	Buffalo	2002-03-09
INN R82 A/S	x:panda	2002-03-09
INN R82 A/S	Strong Base	2002-03-09
INN R82 A/S	Scallop	2002-03-09
INN R82 A/S	Panda Futura	2002-03-09
INN R82 A/S	Panda Futura 5	2002-03-09
INN R82 A/S	Nandu	2002-03-09
INN R82 A/S	Manatee Bath Chair	2002-03-09
INN R82 A/S	High-Low:x Frame	2002-03-09
INN R82 A/S	High-Low Frame	2002-03-09

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020090287060	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	REHAB EQUIPMENT	168 PKG
2020082081276	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	REHAB EQUIPMENT	89 PKG
20200811127227	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	REHAB EQUIPMENT	89 PKG
2020080777678	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	REHAB EQUIPMENT	89 PKG
2020073051091	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	REHAB EQUIPMENT	205 PKG
2020073051091	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	REHAB EQUIPMENT	205 PKG
2020072767969	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	REHAB EQUIPMENT	205 PKG
2020072767969	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	REHAB EQUIPMENT	205 PKG
2020072038971	Stadersand,Federal Republic of Germany -> Charleston, South Carolina	REHAB EQUIPMENT	275 PKG
2020072038977	Stadersand,Federal Republic of Germany -> Charleston, South Carolina	REHAB EQUIPMENT	2 PKG