Etymotic

SAMPLE Foam eartips - jumbo 500/pkg

Registry build 21.09.26
1manufacturer
2catalogue numbers in this listing

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code ETT
Manufacturer City Province Registered as Device types
Guangdong Kelihuan Biotechnology Co., Ltd. Huizhou Guangdong Manufacturer 5

Record

Regulatory record for Etymotic
Listed by Etymotic Research, Inc., United States
FDA product code ETT
Device type Cushion, Earphone (For Audiometric Testing)
Device class Class 1
Regulation 21 CFR 874.1100
Establishment Specification developer, Manufacturer
Premarket notification Exempt
Record published 2023-04-04
Record revised 2025-06-30 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Etymotic
Catalogue number Size Status
ER3-14C-500 In distribution
ER3-14B-500 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Grason & Associates, LLC Grason & Associates, LLC 144
Sanibel Supply Interacoustics A/S 56
OAE Eartips Natus Medical Denmark ApS 9
E-A-Rlink™ 3M Company 8
Sanibel Supply A/S Interacoustics A/S 5
Maico Interacoustics A/S 3
GoCheck Audiometric Headphone Assembly Gobiquity, Inc. 2
Infant E-A-Rtip 3M Company 2
Amplivox Interacoustics A/S 2
Foam Eartip 3C (Jumbo) Natus Manufacturing Limited 1
Interacoustics Interacoustics A/S 1
Foam Eartip, 3B (Small) Natus Manufacturing Limited 1

Showing 12 of 13. All products under Cushion, Earphone (For Audiometric Testing)

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