# Boditech Med Inc. (manufacturer, Chuncheon Gangwon, KR): 9 new FDA device listings, incl. antigens, all groups, streptococcus spp.

**Score:** 75/100

| 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 |

## Why this 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.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
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.