- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Nov 30, 2023
697484936W0105900101HPMacro & Micro-Test Sample Release Reagent 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.
06974849366907HWTS-3005-8CCN-MF-000012807(01)06974849366907
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. For professional use only.
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 →No certificate specifically references this device's Basic UDI-DI.
697484936W0105900101HPOn the marketMacro & Micro-Test Sample Release Reagent697484936W0105900101HPOn the marketMacro & Micro-Test Sample Release Reagent697484936W0105900101HPOn the marketMacro & Micro-Test Sample Release Reagent697484936W0105900101HPOn the marketMacro & Micro-Test Viral DNA/RNA Column697484936W0105900101HPOn the marketMacro & Micro-Test Viral DNA/RNA Kit697484936W0105900101HPOn the marketCertificate 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 →