nCare

FDA UDI

Class I (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name: nCare FDA UDI
Generic Name: Endoscopic video image processing unit FDA UDI
Device Name: nCare, SNGL, ELA, DICOM FDA UDI
Model / Reference: 1006538 FDA UDI
Description: nCare, SNGL, ELA, DICOM FDA UDI

Identifiers

Primary DI / UDI-DI: 00810008180969 FDA UDI
FDA Product Code: LMB FDA UDI
LMD FDA UDI
GMDN Term: Endoscopic video image processing unit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 892.2010 FDA UDI
892.2020 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endoscopic video image processing unit

nCare by Gyrus Acmi, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic video image processing unit.

Pixa — SANTA BARBARA IMAGING SYSTEMS, INC. · Class II
ILO — ILO electronic GmbH · Class I
AURORA® Surgiscope® — Integra Lifesciences Corp. · Class II
VIDEO PROCESSOR — PENTAX of America, Inc. · Class II
Digital Video Processor — Hunan Vathin Medical Instrument Co., Ltd · Class II
ILO — ILO electronic GmbH · Class I
3NT Video Console — 3nt Medical , Ltd. · Class II
HDMI cable — 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 I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Gyrus Acmi, Inc.

Sources (1)

FDA UDI 13ebb9b1-2777-4a85-8a9b-3b481859882d 33 fields · synced Jun 8, 2026