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Light Guide Cable

EUDAMEDFDA UDI

Class I (EU MDR)

Ref FIB-H3045Model FIB-H3045, FIB-H3545, FIB-H3035

by Guangdong Optomedic Technologies, Inc.

Identity

Trade Name
Light Guide Cable EUDAMED
AMNOTEC FDA UDI
Generic Name
Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI
Device Name
Light Guide Cable EUDAMED
VEQTRON ICG/NIR Cold Light Cable, Ø 4.5 mm, L. 300 cm, Autoclavable FDA UDI
Model / Reference
FIB-H3045, FIB-H3545, FIB-H3035 EUDAMED
FIB-H3045 EUDAMED
71-146-30 NIR C-US FDA UDI
Description
VEQTRON ICG/NIR Cold Light Cable, Ø 4.5 mm, L. 300 cm, Autoclavable FDA UDI

Identifiers

Catalog Number
71-146-30 NIR C-US FDA UDI
Primary DI / UDI-DI
06973031299795 EUDAMEDFDA UDI
Basic UDI-DI
697303129WS0701EV EUDAMED
Direct Marketing DI
06973031299795 EUDAMED
FDA Product Code
GCJ FDA UDI
IZI FDA UDI
EMDN Code
Z12029080 VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI-INVASIVE SURGERY - HARDWARE ACCESSORIES EUDAMED
GMDN Term
Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
892.1600 FDA UDI
Market of Registration
Ireland EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Dry Heat Sterilization FDA UDI

Light Guide Cable by Guangdong Optomedic Technologies, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Guangdong Optomedic Technologies, Inc.
EUDAMED SRN
CN-MF-000011588
Authorised Representative
Share info GmbH DE-AR-000005132

Sources (2)

  • EUDAMED 26dfcf9e-4089-4a7e-8902-355d902c80b1 61 fields · synced Jun 18, 2026
  • FDA UDI 0416183b-167a-4cb3-b5ae-a87a9c7aedcd 34 fields · synced May 27, 2026