QDx Instacheck™-II
Device identity and regulatory summary
IVD Class AIVDR 2017/746Not intended for EU market
- UDI-DI
- 08806133010204
- Basic UDI-DI
- 880613301020BG
- Manufacturer
- Boditech Med Inc.
- Manufacturer SRN
- KR-MF-000011028
- Risk class
- IVD Class A
- Legislation
- IVDR 2017/746
- Reference
- FPRR039
- EMDN
- W0201020201
- EMDN description
- IMMUNOCHEMISTRY READERS
- First on market country
- -
- Device status
- Not intended for EU market
- Authorised representative
- Obelis s.a.
- Authorised representative SRN
- BE-AR-000000106
- Last updated
- 16.07.2026 12:43
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