aScope™ 4 Broncho Large 5.8/2.8

FDA UDI

Class II (US FDA UDI)

by Ambu A/S

Identity

Trade Name: aScope™ 4 Broncho Large 5.8/2.8 FDA UDI
Generic Name: Flexible video bronchoscope, single-use FDA UDI
Device Name: Flexible Endoscope FDA UDI
Model / Reference: 478001000 FDA UDI
Description: Flexible Endoscope FDA UDI

Identifiers

Catalog Number: 478001000 FDA UDI
Primary DI / UDI-DI: 05707480135530 FDA UDI
FDA Product Code: EOQ FDA UDI
GMDN Term: Flexible video bronchoscope, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.4680 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Dimensions & Sizes

Size: Length — 600 Millimeter FDA UDI
Outer Diameter — 5.8 Millimeter FDA UDI
Lumen/Inner Diameter — 2.8 Millimeter FDA UDI

Category: Flexible video bronchoscope, single-use

aScope™ 4 Broncho Large 5.8/2.8 by Ambu A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible video bronchoscope, single-use.

Single-Use flexible Video Bronchoscope — HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD. · Class II
Single-Use flexible Video Bronchoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
Single-Use flexible Video Bronchoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
GlideScope® — Verathon Medical (Canada) ULC · Class II
LoopView® — MacroLux Medical Technology Co., Ltd. · Class II
Monarch Bronchoscope — Auris Health, Inc. · Class II
LoopView® — MacroLux Medical Technology Co., Ltd. · Class II
LoopView® — MacroLux Medical Technology Co., Ltd. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Ambu A/S

Sources (1)

FDA UDI ce34fbb0-2733-4ceb-af60-e530ba6e8c80 37 fields · synced May 30, 2026