- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Nov 30, 2023
697484936W0105900101HPMacro & Micro-Test General DNA/RNA Column is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06974849367850HWTS-3021-50CN-MF-000012807(01)06974849367850
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
1 warning recorded — scroll inside the panel to see all entries.
The kit is only used for in vitro diagnosis. Please read the instructions for use carefully before use.
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.
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.
Primary placement in Germany; available across 1 country total.
Placed on the market in Germany; per-country availability dates not published.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105900101REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUSPrimary 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 →697484936W0201020201DGOn the marketMacro & Micro-Test Fluorescence Immunoassay Analyzer697484936W0201020201DGOn the marketMacro & Micro-Test Fluorescence Reader697484936W0201020201DGOn the marketMacro & Micro-Test General DNA/RNA Kit697484936W0105900101HPOn the marketMacro & Micro-Test General DNA/RNA Kit697484936W0105900101HPOn the marketMacro & Micro-Test General DNA/RNA Kit697484936W0105900101HPOn the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
EU-QMS-FI-56762-800162-2026IssuedNotified 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 →