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Sign in to claim this brandBIONEER CORPORATION
South Korea·KR-MF-000018672
Last updated September 17, 2026
Information
- Country
- South Korea
- Address
- 71, Techno 2-ro, Daejeon, South Korea
- Website
- www.bioneer.com/
- —
- —
- [email protected]
- Phone
- +82 42 939 6333
- PRRC Contact
- HANEE PARK
- EUDAMED SRN
- KR-MF-000018672
- FDA FEI Number
- 3020925311
- DUNS Number
- —
Catalogue (14)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ExiPrep™ Dx Blood Viral DNA Kit | K-4474 | EUDAMED | Class A | Active |
| ExiPrep™ 48 SF Genomic DNA Kit | K-4577 | EUDAMED | Class A | Active |
| ExiPrep™ 48 SF Viral DNA/RNA Kit | K-4578 | EUDAMED | Class A | Active |
| ExiPrep™ Dx SF Mycobacteria Genomic DNA Kit | K-4479 | EUDAMED | Class A | Active |
| ExiPrep™ 48 Genomic DNA Kit | K-4574 | EUDAMED | Class A | Active |
| AccuPrep® Dx Viral RNA Extraction Kit | K-3033M | EUDAMED | Class A | Active |
| ExiStation™ FA 96 | A-2500-1 | EUDAMED | Class A | Active |
| ExiStation™ FA DNA/RNA Kit (V3) | K-4815 | EUDAMED | Class A | Active |
| AccuPower® RV Kit (ExiStation™ FA 96) | RVP-3116 | EUDAMED | Class B | Active |
| AccuPower® SARS-CoV-2 Real-Time RT-PCR Kit | NCVM2-1111 | EUDAMED | Class B | Active |
| IRON-qPCR™ RV Kit | QRV-1113 | EUDAMED | Class B | Active |
| ExiPrep™ 48 SF Mycobacteria Genomic DNA Kit | K-4579 | EUDAMED | Class A | Active |
| IRON-qPCR™ | A-2600 | EUDAMED | Class A | Active |
| ExiStation™ FA DNA/RNA Kit (V2) | K-4814 | EUDAMED | Class A | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Authorities
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Bioneer Corporation US