Mirror, Ent

Who Makes This Device Type in China?

4 manufacturers in China hold an FDA registration for this device type, concentrated in Guangdong, Jiangsu and Shandong, and 1 other province.

Bestway Plastic And Metal Products Ltd. Guangdong
Little Doctor Electronic(Nantong) Co., Ltd. Jiangsu, contract manufacturer
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
Xinhua Surgical Instrument Co., Ltd. Shandong

How Is KAI Classified?

Mirror, Ent is FDA product code KAI, Class 1, 21 CFR 874.4420.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Has Gone Wrong With It?

The FDA has recorded 1 recall under this product code since 2024. None was by a company in China. The root cause the FDA records most often is Process control (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Atticus Mirror

3.0 mm, 16 cm, black coated

Laryngeal Mirror

Laryngeal Mirror NO-3, 8" Finish

Michel Rhinoscopic Mirror

Michel Rhinoscopic Mirror #2

Intrace USA

Laryngeal Mirror, Plain Surface, 18 mm Diameter (Fig. 4), Stainless Steel Shaft, Reusable.

Boss Instruments

Mouth Mirror, Plane, Size 5, 6cm, 2 1/2" Box of 12

Indian Head Mirror

Indian Head Mirror Front Surface # 1 Stainless Steel

Inka

Laryngeal Mirror sz:2 14mm 18cm -hexagonal handle

Medetz Surgical Instruments

Laryngeal Mirror with Handle 14mm

Symmetry Hardy™

Symmetry® Mirror; Hardy Transphenoid Instrument Mirror; Adjustable; Locking; 9 1/2 in

Safco Kleer Mirrors

Safco Kleer mirror cone socket #4 12p

Mirror, Round, Polished

very fine, for use with handle 90-220-00, 12 mm, shaft length 125 mm

HNM Medical

House Middle EAR Mirror, 6 1/2", 2MM Mirrors, STR Shaft, ANG 45°

Pilling

Front Surface Mirror 6 Millimeter

Jedmed

Mirror Middle EAR House 45-DEG ANG

Bear

12 catalogue numbers from 8.10.000, listed by Bear-ENT, LLC, United States, under Mirror, Ent. 4 manufacturers in China are registered for this product code.

E. Hahnenkratt GmbH

with handle round, Ø 24 mm

Mytamed

13 catalogue numbers from 8.10.06, listed by Mytamed, Inc., under Mirror, Ent. 4 manufacturers in China are registered for this product code.

Integra®

Integra® Laryngeal Mirror, Stationary Octagonal Handle, Size 000, Diameter 8 mm

Adler Instrument Company

00810123202416

V. Mueller

V. Mueller JAKO LARYNGEAL MIRROR MIRROR DIAMETER 7/16 inches 1.1CM WORKING LENGTH 8-5/8 inches 22CM

Michel Rhinoscopic Laryngeal Mirror

Michel Rhinoscopic Laryngeal Mirror 18 Millimeter Tip Size 3

Millennium

Laryngeal Mirror Octagon Handle, Size 1 Diameter 14mm OL 185mm(7 1/4")

Marina Medical

LASER COATED Laryngeal Mirror #2 (14mm)

Novo Surgical

zenith laryngeal mirror, octagon handle, 8" (20.3 cm), size 2/0, 8.0 mm

Ambler Surgical

Mouth mirror, 2 1/2'', size 5, 15/16'' diamater, front surface, screw-in head only, for use with handle 44-402 or 44-403

Centurion

Sterile #4 Laryngeal Mirror (L500034)

Henry Schein

Mirror Laryngeal W/O Handle

Bausch + Lomb

Mirror, Micro 3MM DIA 18CM LNG

Integra® Jarit®

Integra® Jarit® Laryngeal Mirror, With Threaded Handle, No. 00: 12mm Diameter

MicroFrance®

MicroFrance® Sataloff small mirror, 70 °, 3.5 mm diameter, 250 mm length

Symmetry Surgical

Symmetry® Mirror; Handle Octogonal, Cone Socket Diameter 3mm, OL115mm (4 1/2")

RZ Medizintechnik GmbH

Larynx mirror Fig. 000, 180mm, 7", Ø 6mm with hexagonal handle

Bear

11 catalogue numbers from 8.10.03, listed by Mytamed, Inc., under Mirror, Ent. 4 manufacturers in China are registered for this product code.

Novo Surgical Inc.

zenith laryngeal mirror, octagon handle, 8" (20.3 cm), size 7, 24.0 mm

MSI Precision Specialty Instruments

Laryngeal Mirror, Size (K5)/#3, 20mm, Hexagonal Handle

Avalign

Laryngeal Mirror

BR Surgical, LLC

Laryngeal Mirror w/ handle, size 10 (30mm)

Laryngeal Mirror

Laryngeal Mirror With Handle 10 Millimeter #000 Quantum

Mirror

Laryngeal, NO. 10, 30.5 MM Diameter, Rhodium Plated

Resource

MG Laryngeal Mirror HEX-HDL 20MM 200MM

Integra® Miltex®

Integra® Miltex® Laryngeal Mirror with Threaded Stem 4-3/4" , Size No. 00: 12mm Diameter

Aesculap

Laryngeal Mirror, 7" (180 mm), diam. 30 mm, hexagonal handle, Fig. 10

Medicon

Michel laryng mirror Ø 12mm 27cm

Proscope™

Laryngeal Mirror #3,

Hahnenkratt

with handle hexagonal, Ø 16 mm

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