Lina Medical ApS

Address:FORMERVANGEN 5,GLOSTRUP Hovedstaden,DK

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Hysteroscope (And Accessories) (HIH) (5) Snare, Surgical (GAE) (3) Cystoscope And Accessories, Flexible/Rigid (FAJ) (2) Endoscopic Injection Needle, Gastroenterology-Urology (FBK) (2) Retractor (GAD) (1) Tubing And Tubing/Filter Fits (NVT) (1)

Premarket Exempt

No Yes

Clear

LiNA OperaScopeTM Lasso - 05708265011537 Catalog Number : OP-LAS16-3

Device Description : LiNA OperaScopeTM Lasso is intended for use in hysteroscopy procedures.

Device Class :

Duns Number: 305088619

Premarket Exempt : Yes

Product Code : GAE

Prescription Use : Yes

Device Count : 1

LiNA OperaScope™ Tubing & Drape kit - 05708265011841 Catalog Number : OP-TDK-6

Device Description : Tubing & drape for hysteroscopy

Device Class : 1

Duns Number: 305088619

Premarket Exempt : Yes

Product Code : NVT

Prescription Use : Yes

Device Count : 1

LiNA OperaScope™ Lasso - 05708265011865 Catalog Number : OP-LAS10-3

Device Description : The LiNA OperaScopeTM Lasso is intended for use in hysteroscopy procedures.

Device Class : 1

Duns Number: 305088619

Premarket Exempt : Yes

Product Code : GAE

Prescription Use : Yes

Device Count : 1

LiNA OperaScopeTM Lasso - 05708265011889 Catalog Number : OP-LAS16-3

Device Description : LiNA OperaScopeTM Lasso is intended for use in hysteroscopy procedures.

Device Class : 1

Duns Number: 305088619

Premarket Exempt : Yes

Product Code : GAE

Prescription Use : Yes

Device Count : 1

LiNA OperåScope™ with HDMI cable & LCD - 05708265011933 Catalog Number :

Device Class : 2

Duns Number: 305088619

Premarket Exempt : No

Product Code : HIH

Prescription Use : Yes

Device Count : 1

LiNA Skin Hook™ - 05708265011971 Catalog Number : SH-130

Device Description : Small, angled, extra sharp, dual-pack

Device Class :

Duns Number: 305088619

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 2

LiNA OperåScope™ Needle 4mm - 05708265012299 Catalog Number :

Device Description : LiNA OperåScope™ Needle 4mm, minimum channel diameter: Ø 2mm

Device Class : 2

Duns Number: 305088619

Premarket Exempt : No

Product Code : FBK, HIH

Prescription Use : Yes

Device Count : 1

LiNA OperåScope™ Needle 8mm - 05708265012336 Catalog Number :

Device Description : LiNA OperåScope™ Needle 8mm, minimum channel diameter: Ø 2mm

Device Class : 2

Duns Number: 305088619

Premarket Exempt : No

Product Code : FBK, HIH

Prescription Use : Yes

Device Count : 1

LiNA OperaScope™ with HDMI cable - 05708265012374 Catalog Number :

Device Description : LiNA OperaScope™ with HDMI cable, without on-board LCD screen, intended for hyst LiNA OperaScope™ with HDMI cable, without on-board LCD screen, intended for hysteroscopy and cystoscopy

Device Class : 2

Duns Number: 305088619

Premarket Exempt : No

Product Code : HIH, FAJ

Prescription Use : Yes

Device Count : 1

LiNA OperåScope™ with HDMI cable & LCD - 05708265012398 Catalog Number :

Device Description : LiNA OperåScope™ with HDMI cable & LCD intended for hysteroscopy and cystoscopy

Device Class : 2

Duns Number: 305088619

Premarket Exempt : No

Product Code : HIH, FAJ

Prescription Use : Yes

Device Count : 1

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