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LiNA ScopeVu™

FDA UDI

Class II (US FDA UDI)

by Lina Medical ApS

Identity

Trade Name
LiNA ScopeVu™ FDA UDI
Generic Name
Endoscopic video image processing/light source system FDA UDI
Device Name
LiNA ScopeVu™ Full HD display and light source FDA UDI
Model / Reference
SCP-100-1 FDA UDI
Description
LiNA ScopeVu™ Full HD display and light source FDA UDI

Identifiers

Primary DI / UDI-DI
05708265014002 FDA UDI
510(k) Number
K240227 FDA UDI
FDA Product Code
FAJ FDA UDI
GMDN Term
Endoscopic video image processing/light source system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endoscopic video image processing/light source system

LiNA ScopeVu™ by Lina Medical ApS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic video image processing/light source system.

Cleared under the same submission

K240227 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Lina Medical ApS

Sources (1)

  • FDA UDI 5e39bb02-8128-4adb-83eb-ba811efeeb37 34 fields · synced Jun 7, 2026