Organization name

Nanjing Vazyme Medical Technology Co.,Ltd.

SRN

CN-MF-000031032

Manufacturer status

Active

4 warnings recorded — scroll inside the panel to see all entries.

• CW009

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Spain; available across 1 country total.

Trade name

Glycated Hemoglobin A1c (HbA1c) Test Kit (Quantum Dots Fluorescence Immunochromatography)

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

06979469760647

Basic UDI-DI

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.

B-06979469760647

Reference / catalog number

H7402CC

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

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.

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

Glycated Hemoglobin A1c (HbA1c) Test Kit (Quantum Dots Fluorescence Immunochromatography) is a quantitative in vitro diagnostic medical device for the detection of HbA1c in human whole blood and peripheral blood. The kit is used as an aid to identify whether a patient has short-term stress-related blood glucose elevation or diabetes. It can be used as an indicator for long-term blood glucose control and evaluating the efficacy of clinical diabetes management. It can also be used to assess the occurrence and progression of chronic complications in diabetes, facilitating early prevention of complications in diabetes patients. The kit is intended for professional use only.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0102060109GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)

• IVDD — General medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

No certificate specifically references this device's Basic UDI-DI.