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aScope™ Gastro

FDA UDI

Class II (US FDA UDI)

by Ambu A/S

Identity

Trade Name
aScope™ Gastro FDA UDI
Generic Name
Flexible video gastroscope, single-use FDA UDI
Device Name
aScope Gastro (US version) FDA UDI
Model / Reference
483001000US FDA UDI
Description
aScope Gastro (US version) FDA UDI

Identifiers

Catalog Number
483001000US FDA UDI
Primary DI / UDI-DI
05707480148172 FDA UDI
FDA Product Code
FDS FDA UDI
GMDN Term
Flexible video gastroscope, 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

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

No

FDA UDI

Category: Flexible video gastroscope, single-use

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

Similar devices

Also classified as Flexible video gastroscope, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ambu A/S

Sources (1)

  • FDA UDI f3c66a12-4d59-4a97-93fd-88fcfa61b287 36 fields · synced May 30, 2026