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EUDAMED last updated this device on Jun 5, 2026
697484936HWTS-OT149A5ACarbapenem Resistance Gene Detection Kit (Fluorescence PCR) is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class B. 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.
CN-MF-000012807(01)06974849369649
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.
This kit is only used for in vitro diagnosis, please read the instructions for use carefully before experiment.
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.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
06974849369649Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
697484936HWTS-OT149A5AHWTS-OT149AUDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0104080606NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASEPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →697484936HWTS-OT149A5AOn the marketCarbapenem Resistance Gene Detection Kit (Fluorescence PCR)697484936HWTS-OT149A5AOn the marketCarbapenem Resistance Gene Detection Kit (Fluorescence PCR)697484936HWTS-OT149A5AOn the marketCarbapenem Resistance Gene Detection Kit (Fluorescence PCR)697484936HWTS-OT149A5AOn 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.
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