Ambu® aScope™ 5 Uretero

FDA UDI

Class II (US FDA UDI)

by Ambu A/S

Identity

Trade Name: Ambu® aScope™ 5 Uretero FDA UDI
Generic Name: Flexible video ureterorenoscope, single-use FDA UDI
Device Name: Flexible Ureteroscope, Standard Deflection FDA UDI
Model / Reference: 604101000 FDA UDI
Description: Flexible Ureteroscope, Standard Deflection FDA UDI

Identifiers

Catalog Number: 604101000 FDA UDI
Primary DI / UDI-DI: 05707480161553 FDA UDI
FDA Product Code: FGB FDA UDI
GMDN Term: Flexible video ureterorenoscope, single-use 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

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

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 780 Millimeter FDA UDI
Lumen/Inner Diameter — 1.2 Millimeter FDA UDI
Outer Diameter — 3 Millimeter FDA UDI

Category: Flexible video ureterorenoscope, single-use

Ambu® aScope™ 5 Uretero by Ambu A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible video ureterorenoscope, single-use.

Single-Use Ureterorenoscope — Shenzhen HugeMed Medical Technical Development Co., Ltd. · Class II
REDPINE — Guangzhou Red Pine Medical Instrument Co., Ltd. · Class II
Single-Use Ureterorenoscope — Shenzhen HugeMed Medical Technical Development Co., Ltd. · Class II
REDPINE — Guangzhou Red Pine Medical Instrument Co., Ltd. · Class II
REDPINE — Guangzhou Red Pine Medical Instrument Co., Ltd. · Class II
n.a, — Karl Storz GmbH & Co. KG · Class II
REDPINE — Guangzhou Red Pine Medical Instrument Co., Ltd. · Class II
Ambu® aScope™ 5 Uretero — Ambu A/S · 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 90fdfbb4-097b-4bc8-b730-e2b6920276ee 37 fields · synced Jun 6, 2026