Hi Medical Co., Ltd. (foreign exporter, Seoul, KR): 4 new FDA device listings, incl. applicator, resin

Hi Medical Co., Ltd. (Seoul): 4 new FDA device listings, incl. applicator, resin. Its amount of 4 is above the median of 2 (83rd percentile). Dated 113 days ago, it serves as a historical benchmark. Score 40/100. As of 2026-11-04, 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: 4 · 83th percentile of 2,709 DeviceEstablishmentPulse records · 2.0x the median

Free preview: all 14 published fields of this record are shown below. Locked: 121 related KR DeviceEstablishmentPulse records and the 5-column CSV export.

FieldValue
EstablishmentHi Medical Co., Ltd.
RoleForeign exporter
Establishment typesExport Device to the United States But Perform No Other Operation on Device
LocationSeoul, KR
New listings4
DevicesApplicator, Resin; Holder, Film, X-Ray; Agent, Polishing, Abrasive, Oral Cavity; Scaler, Periodontic
Product codesKXR, EGZ, EJR, EMN
Device classesClass I
Medical specialtiesDental
Brand namesYoung Innovations; Dentsply
First new listing2026-06-03
Latest new listing2026-07-15
FDA registration number3012502601
Registration expires2026-12-31
amount percentile83th of 2,709 (median 2, 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: 2026-07-15
  • Data refreshed: 2026-11-04
  • Refunds on request within 14 days

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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 21:52:36 GMT

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Peer benchmark and outreach value: Hi Medical Co., Ltd. and 122 KR peers

  • KR DeviceEstablishmentPulse records like this one: 122
  • Hi Medical Co., Ltd.'s amount: 83rd percentile of 2,709 records
  • Timing: Low: older than 30 days
  • Estimated pipeline if you contact every KR peer: $24,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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40 / 100 Score

  • Several new listings at once.

What is the DeviceEstablishmentPulse record for Hi Medical Co., Ltd. in Seoul?

Hi Medical Co., Ltd. (Seoul, KR), a foreign exporter, added 4 FDA device listings between 2026-06-03 and 2026-07-15.

How does Hi Medical Co., Ltd. compare to other DeviceEstablishmentPulse records?

Its amount of 4 sits in the upper half (83th percentile) of 2,709 records; the median is 2. It is 113 days old; check the official source for later updates before acting.

Hi Medical Co., Ltd. vs. top 3 peers

OrganizationLocationAmountPercentileRecord date
Hi Medical Co., Ltd.Seoul, KR483rd2026-07-15
Imperial Optical, IncTown Of Mount Royal, Quebec, CA377th2026-10-22
Kash Sales Inc.Richmond Hill Ontario, CA890th2026-10-16
Mka Medikal Ic Ve Dis Ticaret Sanayi Limited SirketiCankaya Ankara, TR992nd2026-10-17

Related records

DeviceEstablishmentPulse: Foreign exporter 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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