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EUDAMED last updated this device on May 25, 2026
B-69509960MNAP01VYBBMNAP01-AOGE is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Zhejiang Orient Gene Biotech Co., Ltd. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
D-69509960MNAP01VYBBMNAP01-AOGED-69509960MNAP01VYBB
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W02050199NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHERPrimary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | Still on market |
CN-MF-000017965Sterile
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 →Certificate health across this manufacturer's portfolio.
V10 092305 0004SupplementedCR-04-1249-874-25SupplementedCR-04-1249-875-25IssuedNotified 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.
View in glossary →Notified 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.
View in glossary →Notified 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.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
B-69509960AMPV01UYBQOn the marketAPA01-AOG48E; APA01-AOG96E; APA01D-AOG48E; APA01D-AOG96EB-69509960AFR01QCQZOn the marketSNCE01-AOG48/ SNCE01-AOG96/ SNCE02-AOG16/ SNCE02-AOG48/ SNCE02-AOG96B-69509960SNCE01X59WOn the marketSDVS01-AOG50E; SDVS01-BOG50E; SDVS01-COG50E; SDVS01-DOG50EB-69509960SDVS0125DNOn the marketAHPV1801-BOG48E，AHPV1801-BOG96EB-69509960AHPV1801-BSKY7On the marketAHSV101-AOG48E; AHSV101-AOG96E; AHSV101D-AOG48E; AHSV101D-AOG96EB-69509960AHSV101W7HFOn the market