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South Korea·KR-MF-000023981
Last updated September 18, 2026
Information
- Country
- South Korea
- Address
- 76, Seori-ro, Yongin-si, Gyeonggi-do, South Korea
- Website
- www.yd-diagnostics.com/2012/eng/
- —
- —
- [email protected]
- Phone
- +82-31-329-2000
- PRRC Contact
- Eunyoung Kim
- EUDAMED SRN
- KR-MF-000023981
- FDA FEI Number
- —
- DUNS Number
- 687769737
Catalogue (38)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| URiSCAN® 2 Gluketo strip | U24 | EUDAMED | Class B | Active |
| URiSCAN® Super Cassette | U81 | EUDAMED | Class B | Active |
| URiSCAN® 11 ACR strip | U63 | EUDAMED | Class B | Active |
| URiSCAN® 7 strip | U27 | EUDAMED | Class B | Active |
| URiSCAN® 10 SGL strip | U39 | EUDAMED | Class B | Active |
| URiSCAN® Super Cassette ACR | U80 | EUDAMED | Class B | Active |
| URiSCAN® Super Cassette | U82 | EUDAMED | Class B | Active |
| URiSCAN® Super Cassette ACR | U83 | EUDAMED | Class B | Active |
| URiSCAN® 8 strip | U26 | EUDAMED | Class B | Active |
| URiSCAN® 2 Gluketo strip | U24 | EUDAMED | Class B | Active |
| URiSCAN® 5 strip | U29 | EUDAMED | Class B | Active |
| URiSCAN® 11 strip | U41 | EUDAMED | Class B | Active |
| URiSCAN® 9 SG strip | U37 | EUDAMED | Class B | Active |
| URiSCAN® 5 HemoketoGPH strip | U22 | EUDAMED | Class B | Active |
| URiSCAN® 4 HemoGPH strip | U12 | EUDAMED | Class B | Active |
| EASYPREP Preservative solution | NGY 01 | EUDAMED | Class A | Active |
| EASYPREP Rinse Solution | EZ 05 | EUDAMED | Class A | Active |
| URiSCAN PRO | M9 | EUDAMED | Class A | Active |
| EASYPREP centrifuge tube | EZ 10 | EUDAMED | Class A | Active |
| Occultech Fecal Occult Blood Rapid Test | K060953 | FDA 510(k) | Class II | Active |
| URiSCAN PluScope Reagent B | USP05-1 | EUDAMED | IVD General | Active |
| URiTROL™ Liquid Level 1, 2 | U5-13 | EUDAMED | Class B | Active |
| URiSCAN PluScope Reagent A | USP04-1 | EUDAMED | IVD General | Active |
| URiTROR™ Liquid Level 1 | U5-11 | EUDAMED | Class B | Active |
| EASYPREP Slide chamber | EZ 07 | EUDAMED | Class A | Active |
| EASYPREP Vial Plug | EZ 12 | EUDAMED | Class A | Active |
| URiTROL™ Liquid Level 2 | U5-12 | EUDAMED | Class B | Active |
| EASYPREP Suspension Buffer | EZ 03 | EUDAMED | Class A | Active |
| URiSCAN Optima | M7 | EUDAMEDFDA UDI | Class A | Active |
| URiSCAN Tracking System | USP-1 | EUDAMED | IVD General | Active |
| EASYPREP Gradient Density Reagent | EZ 02 | EUDAMED | Class A | Active |
| Easyprep® | EZP | EUDAMED | Class A | Active |
| EASYPREP coated slide glass | EZ 06 | EUDAMED | Class A | Active |
| EASYPREP 5ml Tip | EZ 09 | EUDAMED | Class A | Active |
| URiSCAN PluScope Cleanser | USP10 | EUDAMED | IVD General | Active |
| URiSCAN PluScope | USP | EUDAMED | IVD General | Active |
| URiSCAN Super+ | M8 | EUDAMED | Class A | Active |
| EASYPREP Preservative solution | EZ 01 | EUDAMED | Class A | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Yd Diagnostics US