Boditech Med Inc. (manufacturer, Chuncheon Gangwon, KR): 9 new FDA device listings, incl. antigens, all groups, streptococcus spp.
Boditech Med Inc. (Chuncheon Gangwon): 9 new FDA device listings, incl. antigens, all groups, streptococcus spp. Its amount of 9 is top-decile (92nd percentile of 2,570 records). Dated 59 days ago, it serves as a historical benchmark. Score 75/100. 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: 9 · 92th percentile of 2,570 DeviceEstablishmentPulse records · 9.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 116 related KR DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Boditech Med Inc. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Chuncheon Gangwon, KR |
| New listings | 9 |
| Devices | Antigens, All Groups, Streptococcus Spp.; Norovirus Serological Reagent; Radioimmunoassay, Human Growth Hormone; Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine; Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus; Enzyme Linked Immunoabsorbent Assay, Rotavirus; Albumin, Antigen, Antiserum, Control; Radioimmunoassay, C-Peptides Of Proinsulin; Radioimmunoassay, Total Triiodothyronine |
| Product codes | GTY, OUC, CFL, KLI, GQG, LIQ, DCF, JKD, CDP |
| Device classes | Class I, Class II |
| Medical specialties | Microbiology, Clinical Chemistry, Immunology |
| Brand names | AFIAS Strep A; AFIAS NORO; AFIAS IGF-1; AFIAS T4; AFIAS RSV; AFIAS ROTA; AFIAS Rota/Adeno; AFIAS Microalbumin |
| First new listing | 2026-06-01 |
| Latest new listing | 2026-09-07 |
| FDA registration number | 3009491259 |
| Registration expires | 2027-12-31 |
| amount percentile | 92th of 2,570 (median 1, 9.0x median) |
| Peer records CSV (117 KR records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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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: 2026-09-07
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (KR first): Zapalign Inc. (foreign exporter, Anyang-si Gyeonggi, KR) · Samsung Medison Co., Ltd. (manufacturer, Gumi-si Gyeongbuk, · Samsung Medison Co., Ltd. (manufacturer, HONGCHEON-GUN Gangw · Osstem Implant Co.,Ltd. (manufacturer, Yeonsu-gu Incheon, KR · Zimmer Biomet Korea Ltd. (foreign exporter, Seoul, KR) · Browse all by state and category →
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: Boditech Med Inc. and 117 KR peers
- KR DeviceEstablishmentPulse records like this one: 117
- Boditech Med Inc.'s amount: 92nd percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every KR peer: $23,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
75 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
What is the DeviceEstablishmentPulse record for Boditech Med Inc. in Chuncheon Gangwon?
Boditech Med Inc. (Chuncheon Gangwon, KR), a manufacturer, added 9 FDA device listings between 2026-06-01 and 2026-09-07.
How does Boditech Med Inc. compare to other DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 9 is 9.0x the median of 1 across 2,570 records. It is 59 days old; check the official source for later updates before acting. Its Score of 75/100 puts it among the stronger signals in this feed.
Boditech Med Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Boditech Med Inc. | Chuncheon Gangwon, KR | 9 | 92nd | 2026-09-07 |
| Paragon 28 | Englewood, CO | 9 | 92nd | 2026-10-08 |
| Boston Scientific Corporation | Coventry, RI | 10 | 93rd | 2026-10-16 |
| Abyrx, Inc. | Stamford, CT | 7 | 90th | 2026-10-07 |
Related records
DeviceEstablishmentPulse: Manufacturer DeviceEstablishmentPulse: Foreign establishment
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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.