STARLED3 NX

STARLED3 NX Trolley Abps

Registry build 21.09.26
1manufacturer
2catalogue numbers in this listing

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code FSS
Manufacturer City Province Registered as Device types
Shenzhen Kaiyan Medical Equipment Co., Ltd. Shenzhen Guangdong Contract manufacturer 17

Record

Regulatory record for STARLED3 NX
Listed by Acem SPA
FDA product code FSS
Device type Light, Surgical, Floor Standing
Device class Class 2
Regulation 21 CFR 878.4580
Premarket notification Exempt
Record published 2020-01-31
Record revised 2021-01-08 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for STARLED3 NX
Catalogue number Size Status
STARLED3 NX /TB In distribution
STARLED3 NX /T In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Maquet Rolite Maquet Gmbh 35
StarTrol Huot Instruments, LLC 9
HarmonyAIR Steris Corporation 6
Aesculap Aesculap AG 5
Lucea LED® Maquet Gmbh 4
Amtai Amtai Medical Equipment, Inc. 4
Nico Myriad-LX Nico Corporation 3
Sunoptic Technologies Sunoptic Technologies, LLC 3
Aurora Surgical Light Series Skytron, LLC 2
Maxx Luxx LED 160 Avante 2
MS Sim.LED OpL wDB S.i.m.e.o.n. Medical GMBH & Co.KG 2
Nico Myriad-LX Sunoptic Technologies, LLC 2

Showing 12 of 37. All products under Light, Surgical, Floor Standing

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer