Olympus

3 catalogue numbers from WA96105A, listed by Olympus Winter & IBE Gmbh, Germany, under Laryngostroboscope. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26
1manufacturer
3catalogue numbers in this listing

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code EQL
Manufacturer City Province Registered as Device types
Shenzhen Heearly Technology Co., Ltd. Bao An District, Shenzhen Guangdong Contract manufacturer 13

Record

Regulatory record for Olympus
Listed by Olympus Winter & IBE Gmbh, Germany
FDA product code EQL
Device type Laryngostroboscope
Device class Class 1
Regulation 21 CFR 874.4750
Establishment Contract manufacturer, Specification developer, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2023-06-20
Record revised 2023-11-17 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Olympus
Catalogue number Size Status
WA96105A In distribution
WA96100A In distribution
WA97010A In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Jedmed Jedmed Instrument Company 62
Laryngostroboscope Pentax of America, Inc. 22
Laryngostroboscope Karl Storz GmbH & Co. KG 7
Video Laryngostroboscope Pentax of America, Inc. 3
Rigid Scopes Pentax of America, Inc. 3
Pulsar Karl Storz GmbH & Co. KG 2
Atmos Atmos Medizintechnik Gmbh & Co. KG 2
Optomic Optomic España SA 2
Pentax Medical Rigid Laryngostroboscopes Pentax of America, Inc. 1
Pentax Medical Laryngeal Stroboscope Pentax of America, Inc. 1
Machida Machida Endoscope Co., Ltd. 1
Laryngostroboscope National Advanced Endoscopy Devices, Inc. 1

Showing 12 of 14. All products under Laryngostroboscope

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