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Sign in to claim this brandWELLS BIO, INC.
South Korea·KR-MF-000031789
Last updated September 18, 2026
About
We are developing and producing products based on immune diagnosis, biosensor, and molecular diagnosis technology based on immune diagnosis, biosensor and molecular diagnosis technology.
Translated from the manufacturer's own website. Source
Information
- Country
- South Korea
- Address
- 16, Magokjungang 8-ro 1-gil, Seoul, South Korea
- Website
- www.wellsbio.net
- —
- —
- [email protected]
- Phone
- +82 2 3660 6900
- PRRC Contact
- Hyun Kyung Bae
- EUDAMED SRN
- KR-MF-000031789
- FDA FEI Number
- —
- DUNS Number
- 689849476
Catalogue (16)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| careGENE™ Viral/Pathogen HiFi Nucleic Acid Isolation kit | MVP-N09683 | FDA UDI | Class I | Active |
| caerGENE™ Viral/Pathogen HiFi Nucleic Acid Isolation kit-N | MHN-N00082 | FDA UDI | Class I | Active |
| careSTART™ Hb Biosensor Control | HCA-N05082 | EUDAMED | IVD General | Active |
| careSTART™ Total Bilirubin Biosensor Control | HCB-N05082 | EUDAMED | IVD General | Active |
| careSTART™ G6PD Biosensor Analyzer | BGB-E00182 | EUDAMED | Class A | Active |
| careGENE™ STD-12 detection kit | MST-N10082 | EUDAMED | IVD Annex II List B | Active |
| careSTART™ Hb1 Analyzer | BHN-E00182 | EUDAMED | Class A | Active |
| careGENE™ STD-12 detection kit | MST-N05082 | EUDAMED | IVD Annex II List B | Active |
| careSTART™ G6PD Biosensor Strip | BGS-E02582 | EUDAMED | IVD General | Active |
| careSTART™ G6PD Biosensor Control Level II | BGT-N05082 | EUDAMED | IVD General | Active |
| careSTART™ Hb1 Strip | BHP-E02582 | EUDAMED | IVD General | Active |
| careSTART™ G6PD Biosensor Control Level I | BGO-N05082 | EUDAMED | IVD General | Active |
| careSTART™ S1 Total Bilirubin Strip | BSB-E02582 | EUDAMED | IVD General | Active |
| careSTART™ S1 G6PD Strip | BSG-E02582 | EUDAMED | IVD General | Active |
| careSTART™ S1 Hb Strip | BSH-E02582 | EUDAMED | IVD General | Active |
| careSTART™ S1 Analyzer | BSA-E00182 | EUDAMED | Class A | Active |
Related Companies
Authorised Representatives
- MDSS GmbH DE
Importers
Not available yet.
Notified Bodies
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Authorities
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