Nivo

Mirror Simple Stem Socket FS #5 12pk

Registry build 21.09.26
94manufacturers in China registered for this device type
3catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (23), Shanghai (15), Jiangsu (14). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EAX
Manufacturer City Province Registered as Device types
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
Anqing Kangmingna Packaging Co., Ltd. Anqing Anhui Contract manufacturer 39
Beijing Zksk Technology Co., Ltd. Beijing Beijing Contract manufacturer 38
Shun SZE Industrial (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 22
Sino-Vista Dental Instruments Co., Ltd. Zibo Shandong Contract manufacturer 15
Yangzhou Haiwang Toothbrush Factory Yangzhou Jiangsu Contract manufacturer 12
Coda Resources Ltd., Heze China Heze Shandong Contract manufacturer 9
Perfect Group Corp. Ltd. Yangzhou Jiangsu Contract manufacturer 9
Dongguan Shun King Company Limited Dongguan Guangdong Contract manufacturer 4
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222

Showing 12 of 94. All 94 manufacturers in China registered for Mirror, Mouth

Record

Regulatory record for Nivo
Listed by B. ALI Impex, Pakistan
FDA product code EAX
Device type Mirror, Mouth
Device class Class 1
Regulation 21 CFR 872.4565
Establishment Specification developer, Manufacturer
Premarket notification Exempt
Record published 2024-01-29

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Ethylene Oxide, Moist Heat or Steam Sterilization
Over the counter Yes
Label carries lot or batch number, manufacturing date
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Nivo
Catalogue number Size Status
NMSS5 In distribution
NMCS5 In distribution
NMCS4 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
E. Hahnenkratt GmbH E. Hahnenkratt Gmbh 118
Hahnenkratt E. Hahnenkratt Gmbh 108
Integra® Miltex® Integra LifeSciences Production Corporation 86
Crystal HD® Mouth Mirrors Zirc Dental Products, Inc. 65
Sklar® Sklar Corporation 60
HU-Friedy HU-Friedy MFG Co., LLC 59
BMT Medizintechnik GmbH BMT Medizintechnik GmbH 43
Osung MND Osung MND Co., Ltd. 39
Mouth Mirror Handle Zirc Dental Products, Inc. 33
Jedmed Jedmed Instrument Company 31
Plasdent Plasdent Corp. 30
Henry Schein Henry Schein, Inc. 27

Showing 12 of 205. All products under Mirror, Mouth

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