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EUDAMED last updated this device on Aug 4, 2026
B-00850081948735HEA 1.2 BeadChip Kit is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Annex II List A. Manufactured by BioArray Solutions Ltd. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
00850081948735800-10202-08(01)00850081948735
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01030499TISSUE TYPING REAGENTS - OTHER2 warnings recorded — scroll inside the panel to see all entries.
AQUATIC HAZARD (LONG-TERM) - Category 3
US-MF-000022068HL 1804154-1Primary placement in Germany; available across 5 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | May 30, 2013 | Dec 31, 2027 |
| Spain | May 30, 2013 | Dec 31, 2027 |
| France | May 30, 2013 | Dec 31, 2027 |
| Italy | May 30, 2013 | Dec 31, 2027 |
| Portugal | May 30, 2013 | Dec 31, 2027 |
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →IVDR risk classes
IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
088823479020016PMOn the marketBioArray Array Imaging System TM (AIS) 400D08500819481WAYOn the marketHPA BeadChip KitB-00850081948704On the marketMIA FORA NGS MFlex 11 HLA Typing Kit, 24 test88823412W01030403C00000YJOn the marketMIA FORA NGS MFlex 11 HLA Typing Kit, 24 Test08500819481PAJOn the marketCertificate health across this manufacturer's portfolio.
HX 1804154-1SupplementedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
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