Samyang Biopharm Corp. (manufacturer, Daedeok-gu Daejeon, KR): 1 new FDA device listing, incl. suture, surgical, absorbable, polydioxanone

Samyang Biopharm Corp. (Daedeok-gu Daejeon): 1 new FDA device listing, incl. suture, surgical, absorbable, polydioxanone. Its amount of 1 is above the median of 2 (50th percentile). Dated 18 days ago, it is in the active follow-up window. Score 70/100. 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: 1 · 50th percentile of 2,709 DeviceEstablishmentPulse records · 0.5x the median

Free preview: all 15 published fields of this record are shown below. Locked: 121 related KR DeviceEstablishmentPulse records and the 5-column CSV export.

FieldValue
EstablishmentSamyang Biopharm Corp.
Owner / operatorSamyang Biopharm Corporation
RoleManufacturer
Establishment typesManufacture Medical Device
LocationDaedeok-gu Daejeon, KR
New listings1
DevicesSuture, Surgical, Absorbable, Polydioxanone
Product codesNEW
Device classesClass II
Medical specialtiesGeneral, Plastic Surgery
Brand namesMONOFIX PDO
First new listing2026-10-19
Latest new listing2026-10-19
FDA registration number3026229535
Registration expires2027-12-31
amount percentile50th of 2,709 (median 2, 0.5x 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: 2026-10-19
  • 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: Samyang Biopharm Corp. and 122 KR peers

  • KR DeviceEstablishmentPulse records like this one: 122
  • Samyang Biopharm Corp.'s amount: 50th percentile of 2,709 records
  • Timing: Medium: dated in the last 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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70 / 100 Score

  • Brings its own devices to market: buys manufacturing, sterilization and QMS help.
  • Class II or III devices: QMS and regulatory demands.
  • Listed in the last 45 days.

What is the DeviceEstablishmentPulse record for Samyang Biopharm Corp. in Daedeok-gu Daejeon?

Samyang Biopharm Corp. (Daedeok-gu Daejeon, KR), a manufacturer, added 1 FDA device listing on 2026-10-19.

How does Samyang Biopharm Corp. compare to other DeviceEstablishmentPulse records?

Its amount of 1 sits in the upper half (50th percentile) of 2,709 records; the median is 2. It is 18 days old, still within a typical 45-day follow-up window. Its Score of 70/100 puts it among the stronger signals in this feed.

Samyang Biopharm Corp. vs. top 3 peers

OrganizationLocationAmountPercentileRecord date
Samyang Biopharm Corp.Daedeok-gu Daejeon, KR150th2026-10-19
Applied Medical Resources Corp.Rsm, CA377th2026-10-23
Tornier, Inc.Bloomington, MN377th2026-10-21
Treace Medical Concepts, Inc.Ponte Vedra, FL377th2026-10-20

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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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