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LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58…

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K233779Ref B38-CModel B27-C/ B27-CG/ B38-C/ B38-CG/ B50-C/ B50-CG/ B58-C/ B58-CG

by MacroLux Medical Technology Co., Ltd.

Identity

Trade Name
LoopView EUDAMED
LoopView® FDA UDI
Generic Name
Flexible video bronchoscope, single-use FDA UDI
Device Name
Single-Use Digital Flexible Bronchoscope EUDAMED
LoopView®, Single-Use Digital Flexible Bronchoscope, B38-C, multi-language FDA UDI
Model / Reference
B38-C EUDAMEDFDA UDI
B27-C/ B27-CG/ B38-C/ B38-CG/ B50-C/ B50-CG/ B58-C/ B58-CG EUDAMED
Description
LoopView®, Single-Use Digital Flexible Bronchoscope, B38-C, multi-language FDA UDI

Identifiers

Primary DI / UDI-DI
06975339622244 EUDAMEDFDA UDI
Basic UDI-DI
697533962003MN EUDAMED
510(k) Number
K233779 FDA 510(k)
FDA Product Code
EOQ FDA 510(k)FDA UDI
EMDN Code
Z12020802 VIDEO BRONCHOSCOPES EUDAMED
GMDN Term
Flexible video bronchoscope, single-use FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 874.4680 FDA 510(k)
Regulation Number
874.4680 FDA 510(k)FDA UDI
Market of Registration
France EUDAMED
Advisory Committee
Ear, Nose, Throat FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

The LoopView Single-Use Digital Flexible Bronchoscope is a flexible endoscope designed for visual examination of the airways, including the trachea and bronchi. It integrates digital imaging technology to provide high-resolution, real-time visualization of internal structures, aiding in diagnostic and therapeutic procedures within the respiratory system.

This system comprises a single-use bronchoscope (handle, cable, and flexible body) paired with the reusable ViewHub Video Processor (S13), which processes and displays imaging data. The bronchoscope is sterile, intended for single-use, and compatible with standard medical accessories. It operates in clinical settings such as otolaryngology and is authorized under FDA 510K and MDR regulations.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50 ..., Macrolux Loopview® | IES Medical, PDF April 5, 2024 MacroLux Medical Technology Co., Ltd. ℅ Jie Yang ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
MacroLux Medical Technology Co., Ltd.

Sources (3)

  • FDA 510(k) K233779 24 fields · synced Sep 18, 2026
  • FDA UDI e24c2144-5fb1-4ce9-af51-ad3a788b6b9b 33 fields · synced May 30, 2026
  • EUDAMED e3481d88-e767-4833-93fb-0defd57bc322 61 fields · synced Jul 15, 2026