Gn Resound China, Ltd. (contract manufacturer, XIAMEN Fujian, CN): 2 new FDA device listings, incl. self-fitting air-conduction hearing aid, over the counter

Gn Resound China, Ltd. (XIAMEN Fujian): 2 new FDA device listings, incl. self-fitting air-conduction hearing aid, over the counter. Its amount of 2 is above the median of 1 (69th percentile). Dated 80 days ago, it serves as a historical benchmark. Score 55/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).

Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)

amount: 2 · 69th percentile of 2,570 DeviceEstablishmentPulse records · 2.0x the median

Free preview: all 15 published fields of this record are shown below. Locked: 499 related CN DeviceEstablishmentPulse records and the 5-column CSV export.

FieldValue
EstablishmentGn Resound China, Ltd.
Owner / operatorGN Hearing A/S
RoleContract manufacturer
Establishment typesManufacture Medical Device for Another Party (Contract Manufacturer)
LocationXIAMEN Fujian, CN
New listings2
DevicesSelf-Fitting Air-Conduction Hearing Aid, Over The Counter; Hearing Aid, Air-Conduction With Wireless Technology, Prescription
Product codesQUH, OSM
Device classesClass II
Medical specialtiesEar, Nose, Throat
Brand namesEnhance Select M2; Enhance Select M3; Enhance Select M1; Enhance Select 550
First new listing2026-08-17
Latest new listing2026-08-17
FDA registration number3003303986
Registration expires2027-12-31
amount percentile69th of 2,570 (median 1, 2.0x median)
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL

  • Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
  • Record date: 2026-08-17
  • Data refreshed: 2026-10-28
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT

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Peer benchmark and outreach value: Gn Resound China, Ltd. and 687 CN peers

  • CN DeviceEstablishmentPulse records like this one: 687
  • Gn Resound China, Ltd.'s amount: 69th percentile of 2,570 records
  • Timing: Low: older than 30 days
  • Estimated pipeline if you contact every CN peer: $137,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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55 / 100 Score

  • Contract manufacturer or sterilizer adding work.
  • Class II or III devices: QMS and regulatory demands.

What is the DeviceEstablishmentPulse record for Gn Resound China, Ltd. in XIAMEN Fujian?

Gn Resound China, Ltd. (XIAMEN Fujian, CN), a contract manufacturer, added 2 FDA device listings on 2026-08-17.

How does Gn Resound China, Ltd. compare to other DeviceEstablishmentPulse records?

Its amount of 2 sits in the upper half (69th percentile) of 2,570 records; the median is 1. It is 80 days old; check the official source for later updates before acting.

Gn Resound China, Ltd. vs. top 3 peers

OrganizationLocationAmountPercentileRecord date
Gn Resound China, Ltd.XIAMEN Fujian, CN269th2026-08-17
Tecomet Inc.Wilmington, MA377th2026-10-15
Bard Shannon LimitedHumacao, PR377th2026-10-14
Orchid Orthopedic Solutions Oregon, Inc.Oregon City, OR377th2026-10-05

Related records

DeviceEstablishmentPulse: Contract manufacturer DeviceEstablishmentPulse: Foreign establishment

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✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days

From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.

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