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 Number: 3002626775
• FEI Number: 3002626775
• Name: Michael van de Woude
• Owner & Operator: LINA MEDICAL APS
• Contact Address: FORMERVANGEN 5 --; GLOSTRUP DK-84 Region Hovedstaden 2600 DK
• Official Correspondent:
  • ANNE - KLITGAARD
  • 45-432-96666-x
• US Agent:
  • Michael van de Woude
  • Emergo Global Representation LLC
  • 512 3279997
  • 512 3279998
  • usagent@ul.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2500 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 Number: 3012910653
• FEI Number: 3012910653
• Name: Michael van de Woude
• Owner & Operator: LINA MEDICAL APS
• Contact Address: FORMERVANGEN 5 --; GLOSTRUP DK-84 Region Hovedstaden 2600 DK
• Official Correspondent:
  • ANNE - KLITGAARD
  • 45-432-96666-x
• US Agent:
  • Michael van de Woude
  • Emergo Global Representation
  • 512 3279997
  • usagent@ul.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2500 Bee Cave Road Bldg 1, Suite 300; Austin, TX 78746 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 3007699067
• FEI Number: 3007699067
• Name: LiNA Medical Polska sp. z o.o
• Owner & Operator: LINA MEDICAL APS
• Contact Address: FORMERVANGEN 5 --; GLOSTRUP DK-84 Region Hovedstaden 2600 DK
• Official Correspondent:
  • ANNE - KLITGAARD
  • 45-432-96666-x
• US Agent:
  • Michael van de Woude
  • Emergo Global Representation LLC
  • 512 3279997
  • 512 3279998
  • usagent@ul.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: ul. 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	Device	Date
GUDID 05708265013326 Lina Medical ApS	LiNA Xcise™, Laparoscopic Morcellator MOR-1515-1	2024-10-02
GUDID 05708265014002 Lina Medical ApS	LiNA ScopeVu™	2024-10-01
GUDID 05708265013975 Lina Medical ApS	LiNA CystoVu™ HD	2024-10-01
GUDID 05708265013944 Lina Medical ApS	LiNA CystoVu™ HD	2024-10-01
GUDID 05708265013340 Lina Medical ApS	LiNA Xcise™, Laparoscopic Morcellator MOR-1515-6	2024-10-01
GUDID 05708265011537 Lina Medical ApS	LiNA OperaScopeTM Lasso OP-LAS16-3	2024-09-27
GUDID 05708265011520 Lina Medical ApS	LiNA OperaScope™ Lasso OP-LAS10-3	2024-09-25
GUDID 05708265008483 Lina Medical ApS	LiNA PowerBlade Plus™ HC	2023-06-15
GUDID 05708265005949 Lina Medical ApS	LiNA PowerBlade™	2023-06-15
GUDID 05708265005932 Lina Medical ApS	LiNA PowerBlade™	2023-06-15
GUDID 05708265005703 Lina Medical ApS	Pleura-Guard	2023-06-15
GUDID 05708265004737 Lina Medical ApS	LiNA PowerBlade Plus™	2023-06-15
GUDID 05708265004454 Lina Medical ApS	LiNA PowerBlade™	2023-06-15
GUDID 05708265004430 Lina Medical ApS	LiNA PowerBlade™	2023-06-15
GUDID 05708265001088 Lina Medical ApS	LiNA PowerBlade™	2023-06-15
GUDID 05708265000036 Lina Medical ApS	EpiGuard	2023-06-15
GUDID 05708265000012 Lina Medical ApS	Drain Guard	2023-06-15
GUDID 05708265012343 Lina Medical ApS	LiNA OperåScope™ Needle 8mm	2022-10-11
GUDID 05708265012305 Lina Medical ApS	LiNA OperåScope™ Needle 4mm	2022-10-11
GUDID 05708265013913 Lina Medical ApS	LiNA OperåScope™ with HDMI cable & LCD	2022-10-10
PMN K221085 LiNA Medical ApS	LiNA OperaScope Needle	2022-09-02
GUDID 05708265013449 Lina Medical ApS	LiNA OperåScope™ Recording Module OP-RM-1	2021-12-13
GUDID 05708265013418 Lina Medical ApS	LiNA OperåScope™ with HDMI cable & LCD	2021-12-13
GUDID 05708265013395 Lina Medical ApS	LiNA OperaScope™ with HDMI cable	2021-12-13
GUDID 05708265012534 Lina Medical ApS	LiNA Xcise™, Laparoscopic Morcellator MOR2-1515-6	2020-12-10
GUDID 05708265012480 Lina Medical ApS	LiNA OperaScope™ Tubing & Drape kit OP-TDK-6	2020-09-14
GUDID 05708265012473 Lina Medical ApS	LiNA OperaScope™ Rat Tooth Alligator Grasper OP-GRA-6	2020-09-14
GUDID 05708265012404 Lina Medical ApS	LiNA OperåScope™ with HDMI cable & LCD	2020-09-14
GUDID 05708265012381 Lina Medical ApS	LiNA OperaScope™ with HDMI cable	2020-09-14
GUDID 05708265012459 Lina Medical ApS	LiNA OperaScope™ Biopsy Forceps OP-FCP-6	2020-08-11
GUDID 05708265011940 Lina Medical ApS	LiNA OperåScope™ with HDMI cable & LCD	2020-08-11
GUDID 05708265011896 Lina Medical ApS	LiNA OperaScopeTM Lasso OP-LAS16-3	2020-08-11
GUDID 05708265011872 Lina Medical ApS	LiNA OperaScope™ Lasso OP-LAS10-3	2020-08-11
GUDID 05708265011858 Lina Medical ApS	LiNA OperaScope™ Tubing & Drape kit OP-TDK-6	2020-08-11
GUDID 05708265011186 Lina Medical ApS	LiNA OperaScope™ Tubing & Drape kit OP-TDK-6	2020-08-11
GUDID 05708265010264 Lina Medical ApS	LiNA OperaScope™ with HDMI cable	2020-03-30
GUDID 05708265010950 Lina Medical ApS	LiNA OperåScope™ with HDMI cable & LCD OP‐201‐6	2020-03-05
GUDID 05708265010318 Lina Medical ApS	LiNA OperåScope™ with HDMI cable & LCD OP‐201‐6	2020-03-05
PMN K193007 LiNA Medical ApS	LiNA OperaScope With HDMI Cable And On-board LCD - 6 Units, LiNA OperaScope Recording Module	2020-01-17
GUDID 05708265011506 Lina Medical ApS	LiNA OperaScope™ Scissors OP-SCI-3	2019-07-08
GUDID 05708265010233 Lina Medical ApS	LiNA OperåScope™ Recording Module OP‐RM‐1	2019-06-07
GUDID 05708265001040 Lina Medical ApS	LiNA PowerBlade™ 5005-C-160	2019-04-23
GUDID 05708265001026 Lina Medical ApS	LiNA PowerBlade™ 5005-160	2019-04-23
GUDID 05708265000838 Lina Medical ApS	LiNA Skin Hook™ SH-220	2019-04-23
GUDID 05708265000821 Lina Medical ApS	LiNA Skin Hook™ SH-120	2019-04-23
GUDID 05708265000814 Lina Medical ApS	LiNA Skin Hook™ SH-110	2019-04-23
GUDID 05708265000685 Lina Medical ApS	LiNA PowerBlade™ 5010-160	2019-04-23
GUDID 05708265000678 Lina Medical ApS	LiNA PowerBlade™ 5010	2019-04-23
GUDID 05708265000654 Lina Medical ApS	LiNA PowerBlade™ 5005-C	2019-04-23
GUDID 05708265000647 Lina Medical ApS	LiNA PowerBlade™ 5005-420	2019-04-23
GUDID 05708265000630 Lina Medical ApS	LiNA PowerBlade™ 5005	2019-04-23
GUDID 05708265010592 Lina Medical ApS	LiNA OperaScope™ Tubing & Drape kit OP-TDK-6	2019-04-09
PMN K182224 LiNA Medical APS	SafeAir Smoke Evacuator Compact	2019-02-07
GUDID 05708265004652 Lina Medical ApS	LiNA Bipolar Loop™ BL-240	2019-02-07
GUDID 05708265004638 Lina Medical ApS	LiNA Bipolar Loop™ BL-200	2019-02-07
GUDID 05708265004614 Lina Medical ApS	LiNA Bipolar Loop™ BL-160	2019-02-07
PMN K182354 LiNA Medical ApS	SafeAir Telescopic Smoke Pencil	2018-12-14
GUDID 05708265010226 Lina Medical ApS	LiNA OperaScope™ Rat Tooth Alligator Grasper OP-GRA-6	2018-05-14
GUDID 05708265010202 Lina Medical ApS	LiNA OperaScope™ Scissors OP-SCI-6	2018-05-14
GUDID 05708265010189 Lina Medical ApS	LiNA OperaScope™ Biopsy Forceps OP-FCP-6	2018-05-14
NVT Michael van de Woude [LINA MEDICAL APS]	(OP-TDK-6) LiNA OperaScope? Tubing & Drape Kit	2018-04-09
NVT LiNA Medical Polska sp. z o.o [LINA MEDICAL APS]	(OP-TDK-6) LiNA OperaScope? Tubing & Drape Kit	2018-04-09
GUDID 05708265010295 Lina Medical ApS	LiNA OperåScope™ with HDMI cable & LCD OP‐201‐1	2018-03-29
GUDID 05708265010059 Lina Medical ApS	Meniett ® Pulse Generator- LOANER MT-GEN-LO	2018-03-29
GUDID 05708265005079 Lina Medical ApS	Meniett™ Power Supply MT-POW	2018-03-29
GUDID 05708265005062 Lina Medical ApS	Meniett ® Pulse Generator MT-GEN	2018-03-29
GUDID 05708265005055 Lina Medical ApS	Meniett™ Earplug Connector MT-EP-CON	2018-03-29
GUDID 05708265005048 Lina Medical ApS	Meniett™ Earplug, Clear, 19 mm MT-EP-19	2018-03-29
GUDID 05708265005031 Lina Medical ApS	Meniett™ Earplug, Grey, 18 mm MT-EP-18	2018-03-29
GUDID 05708265005024 Lina Medical ApS	Meniett™ Earplug, Blue, 16 mm MT-EP-16	2018-03-29
GUDID 05708265005017 Lina Medical ApS	Meniett™ Earplug, Green, 14 mm MT-EP-14	2018-03-29
GUDID 05708265005000 Lina Medical ApS	Meniett™ Earplug, Red, 12.5 mm MT-EP-12-5	2018-03-29
GUDID 05708265004997 Lina Medical ApS	Meniett™ Earplug, Grey, 11 mm MT-EP-11	2018-03-29
GUDID 05708265004980 Lina Medical ApS	Meniett™ Carrying Case MT-CASE	2018-03-29
GUDID 05708265004973 Lina Medical ApS	Meniett™ Power Cord, North America MT-CAB-US	2018-03-29
GUDID 05708265004966 Lina Medical ApS	Meniett™ Power Cord, United Kingdom and Ireland MT-CAB-UK	2018-03-29
GUDID 05708265004959 Lina Medical ApS	Meniett™ Power Cord, Continental Europe MT-CAB-EU	2018-03-29
GUDID 05708265004942 Lina Medical ApS	Meniett™ Power Cord, Australia and New Zeland MT-CAB-AUS	2018-03-29
GUDID 05708265004935 Lina Medical ApS	Meniett™ Battery Pack, 9.6 VDC MT-BATT	2018-03-29
GUDID 05708265004713 Lina Medical ApS	LiNA Xcise™, Laparoscopic Morcellator MOR-1515-6	2018-03-29
GUDID 05708265004515 Lina Medical ApS	LiNA Xcise™, Laparoscopic Morcellator MOR-1515-1	2018-03-29
GUDID 05708265004027 Lina Medical ApS	LiNA Gold Loop™ EL-240-8	2018-03-29
GUDID 05708265002269 Lina Medical ApS	LiNA SeaStar™ 4000-S-Q	2018-03-29
GUDID 05708265001361 Lina Medical ApS	LiNA Gold Loop™ EL-200-8	2018-03-29
GUDID 05708265001323 Lina Medical ApS	LiNA Gold Loop™ EL-160-8	2018-03-29
GUDID 05708265000883 Lina Medical ApS	LiNA SeaStar™ 4000-S-VV	2018-03-29
GUDID 05708265000876 Lina Medical ApS	LiNA SeaStar™ 4000-S-VS	2018-03-29
GUDID 05708265000869 Lina Medical ApS	LiNA SeaStar™ 4000-S-VL	2018-03-29
GUDID 05708265000852 Lina Medical ApS	LiNA SeaStar™ 4000-S-SS	2018-03-29
GUDID 05708265000845 Lina Medical ApS	LiNA SeaStar™ 4000-S-SL	2018-03-29
PMN K171113 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 Module	2018-01-04
PMN K143145 LiNA Medical ApS	SafeAir Smoke Pencil	2014-12-04
PMN K142757 LiNA Medical ApS	LiNA PowerBlade Plus HC	2014-10-23
PMN K142538 LINA MEDICAL APS	LiNA SafeAir Smoke Pencil	2014-10-06
PMN K132135 LINA MEDICAL APS	LINA GOLD LOOP HC	2014-01-31
PMN K132837 LINA MEDICAL APS	LINA POWERBLADE PLUS	2013-12-19
PMN K130305 LINA MEDICAL APS	LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE	2013-07-24
PMN K101458 LINA MEDICAL APS	LINA XCISE MODEL MOR-1515	2011-03-11
PMN K070315 LINA MEDICAL APS	LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8	2007-10-30
PMN K063025 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

Similar & Related FDA Registered Companies

• LiNA Medical International Operations AG
• LINA MEDICAL CML APS

Related Finance Registrations

NCAGE Code	R4767	LINA MEDICAL APS
CAGE Code	R4767	LINA MEDICAL APS

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2018031944383	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	MEDICAL EQUIPMENT HS CODE 901890840040990000	2 PKG