Lina Medical A P S

FDA Filings

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

FDA Registration(s)
Registration Number3002626775
FEI Number3002626775
NameMichael van de Woude
Owner & OperatorLINA MEDICAL APS
Contact AddressFORMERVANGEN 5 --
GLOSTRUP DK-84 Region Hovedstaden 2600 DK
Official Correspondent
  • ANNE - KLITGAARD
  • 45-432-96666-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2500 Bee Cave Road Bldg 1, Suite 300
Austin, TX 78746 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device



Registration Number3012910653
FEI Number3012910653
NameMichael van de Woude
Owner & OperatorLINA MEDICAL APS
Contact AddressFORMERVANGEN 5 --
GLOSTRUP DK-84 Region Hovedstaden 2600 DK
Official Correspondent
  • ANNE - KLITGAARD
  • 45-432-96666-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2500 Bee Cave Road Bldg 1, Suite 300
Austin, TX 78746 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number3007699067
FEI Number3007699067
NameLiNA Medical Polska sp. z o.o
Owner & OperatorLINA MEDICAL APS
Contact AddressFORMERVANGEN 5 --
GLOSTRUP DK-84 Region Hovedstaden 2600 DK
Official Correspondent
  • ANNE - KLITGAARD
  • 45-432-96666-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Addressul. Rolna 8A Sady
Tarnowo Podgorne, 62-080 PL
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



FDA Owner/Operator Registration

FDA Filings

Device
Company
DeviceDate
LiNA Medical ApS
LiNA OperaScope Needle2022-09-02
Lina Medical ApS
LiNA OperåScope™ Recording Module OP-RM-12021-12-13
Lina Medical ApS
LiNA OperåScope™ with HDMI cable & LCD 2021-12-13
Lina Medical ApS
LiNA OperaScope™ with HDMI cable 2021-12-13
Lina Medical ApS
LiNA Xcise™, Laparoscopic Morcellator MOR2-1515-62020-12-10
Lina Medical ApS
LiNA OperaScope™ Tubing & Drape kit OP-TDK-62020-09-14
Lina Medical ApS
LiNA OperaScope™ Rat Tooth Alligator Grasper OP-GRA-62020-09-14
Lina Medical ApS
LiNA OperåScope™ with HDMI cable & LCD 2020-09-14
Lina Medical ApS
LiNA OperaScope™ with HDMI cable 2020-09-14
Lina Medical ApS
LiNA OperaScope™ Biopsy Forceps OP-FCP-62020-08-11
Lina Medical ApS
LiNA OperåScope™ with HDMI cable & LCD 2020-08-11
Lina Medical ApS
LiNA OperaScopeTM Lasso OP-LAS16-32020-08-11
Lina Medical ApS
LiNA OperaScope™ Lasso OP-LAS10-32020-08-11
Lina Medical ApS
LiNA OperaScope™ Tubing & Drape kit OP-TDK-62020-08-11
Lina Medical ApS
LiNA OperaScope™ Tubing & Drape kit OP-TDK-62020-08-11
Lina Medical ApS
LiNA OperaScope™ with HDMI cable 2020-03-30
Lina Medical ApS
LiNA OperåScope™ with HDMI cable & LCD OP‐201‐62020-03-05
Lina Medical ApS
LiNA OperåScope™ with HDMI cable & LCD OP‐201‐62020-03-05
LiNA Medical ApS
LiNA OperaScope With HDMI Cable And On-board LCD - 6 Units, LiNA OperaScope Recording Module2020-01-17
Lina Medical ApS
LiNA OperaScope™ Scissors OP-SCI-32019-07-08
Lina Medical ApS
LiNA OperåScope™ Recording Module OP‐RM‐12019-06-07
Lina Medical ApS
LiNA PowerBlade™ 5005-C-1602019-04-23
Lina Medical ApS
LiNA PowerBlade™ 5005-1602019-04-23
Lina Medical ApS
LiNA Skin Hook™ SH-2202019-04-23
Lina Medical ApS
LiNA Skin Hook™ SH-1202019-04-23
Lina Medical ApS
LiNA Skin Hook™ SH-1102019-04-23
Lina Medical ApS
LiNA PowerBlade™ 5010-1602019-04-23
Lina Medical ApS
LiNA PowerBlade™ 50102019-04-23
Lina Medical ApS
LiNA PowerBlade™ 5005-C2019-04-23
Lina Medical ApS
LiNA PowerBlade™ 5005-4202019-04-23
Lina Medical ApS
LiNA PowerBlade™ 50052019-04-23
Lina Medical ApS
LiNA OperaScope™ Tubing & Drape kit OP-TDK-62019-04-09
LiNA Medical APS
SafeAir Smoke Evacuator Compact2019-02-07
Lina Medical ApS
LiNA Bipolar Loop™ BL-2402019-02-07
Lina Medical ApS
LiNA Bipolar Loop™ BL-2002019-02-07
Lina Medical ApS
LiNA Bipolar Loop™ BL-1602019-02-07
LiNA Medical ApS
SafeAir Telescopic Smoke Pencil2018-12-14
Lina Medical ApS
LiNA OperaScope™ Rat Tooth Alligator Grasper OP-GRA-62018-05-14
Lina Medical ApS
LiNA OperaScope™ Scissors OP-SCI-62018-05-14
Lina Medical ApS
LiNA OperaScope™ Biopsy Forceps OP-FCP-62018-05-14
Michael van de Woude [LINA MEDICAL APS]
(OP-TDK-6) LiNA OperaScope? Tubing & Drape Kit2018-04-09
LiNA Medical Polska sp. z o.o [LINA MEDICAL APS]
(OP-TDK-6) LiNA OperaScope? Tubing & Drape Kit2018-04-09
Lina Medical ApS
LiNA OperåScope™ with HDMI cable & LCD OP‐201‐12018-03-29
Lina Medical ApS
Meniett ® Pulse Generator- LOANER MT-GEN-LO2018-03-29
Lina Medical ApS
Meniett™ Power Supply MT-POW2018-03-29
Lina Medical ApS
Meniett ® Pulse Generator MT-GEN2018-03-29
Lina Medical ApS
Meniett™ Earplug Connector MT-EP-CON2018-03-29
Lina Medical ApS
Meniett™ Earplug, Clear, 19 mm MT-EP-192018-03-29
Lina Medical ApS
Meniett™ Earplug, Grey, 18 mm MT-EP-182018-03-29
Lina Medical ApS
Meniett™ Earplug, Blue, 16 mm MT-EP-162018-03-29
Lina Medical ApS
Meniett™ Earplug, Green, 14 mm MT-EP-142018-03-29
Lina Medical ApS
Meniett™ Earplug, Red, 12.5 mm MT-EP-12-52018-03-29
Lina Medical ApS
Meniett™ Earplug, Grey, 11 mm MT-EP-112018-03-29
Lina Medical ApS
Meniett™ Carrying Case MT-CASE2018-03-29
Lina Medical ApS
Meniett™ Power Cord, North America MT-CAB-US2018-03-29
Lina Medical ApS
Meniett™ Power Cord, United Kingdom and Ireland MT-CAB-UK2018-03-29
Lina Medical ApS
Meniett™ Power Cord, Continental Europe MT-CAB-EU2018-03-29
Lina Medical ApS
Meniett™ Power Cord, Australia and New Zeland MT-CAB-AUS2018-03-29
Lina Medical ApS
Meniett™ Battery Pack, 9.6 VDC MT-BATT2018-03-29
Lina Medical ApS
LiNA Xcise™, Laparoscopic Morcellator MOR-1515-62018-03-29
Lina Medical ApS
LiNA Xcise™, Laparoscopic Morcellator MOR-1515-12018-03-29
Lina Medical ApS
LiNA Gold Loop™ EL-240-82018-03-29
Lina Medical ApS
LiNA SeaStar™ 4000-S-Q2018-03-29
Lina Medical ApS
LiNA Gold Loop™ EL-200-82018-03-29
Lina Medical ApS
LiNA Gold Loop™ EL-160-82018-03-29
Lina Medical ApS
LiNA SeaStar™ 4000-S-VV2018-03-29
Lina Medical ApS
LiNA SeaStar™ 4000-S-VS2018-03-29
Lina Medical ApS
LiNA SeaStar™ 4000-S-VL2018-03-29
Lina Medical ApS
LiNA SeaStar™ 4000-S-SS2018-03-29
Lina Medical ApS
LiNA SeaStar™ 4000-S-SL2018-03-29
LiNA Medical ApS
LiNA OperaScope With HDMI Cable And On-board LCD-single Unit, LiNA OperaScope With HDMI Cable And On-board LCD-6 Units, LiNA OperaScope Recording Module2018-01-04
LiNA Medical ApS
SafeAir Smoke Pencil2014-12-04
LiNA Medical ApS
LiNA PowerBlade Plus HC2014-10-23
LINA MEDICAL APS
LiNA SafeAir Smoke Pencil2014-10-06
LINA MEDICAL APS
LINA GOLD LOOP HC2014-01-31
LINA MEDICAL APS
LINA POWERBLADE PLUS2013-12-19
LINA MEDICAL APS
LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE2013-07-24
LINA MEDICAL APS
LINA XCISE MODEL MOR-15152011-03-11
LINA MEDICAL APS
LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-82007-10-30
LINA MEDICAL APS
LINA POWERBLADE, MODEL 5005,5005-E,5005-C,5005-150,5000-C-150,5005-E-C-150,5005-420,5005-C-420,5005-E-420,5005-E-C-420,2006-12-01

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2018031944383Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaMEDICAL EQUIPMENT HS CODE 9018908400409900002 PKG

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