Automatic fluorescence microscopic image scanning analyzer

Organization name

Dezhou Guoke Medical Technology Co., Ltd.

SRN

CN-MF-000044128

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW011

  Stay away from sources of high intensity electromagnetic field interference Avoid installing the instrument in high temperature, humidity, dust and direct sunlight. Avoid shocks and vibrations. Ventilation requirements: avoid using the instrument in a closed environment, and leave at least 15cm distance between the instrument and the wall or other equipment around to ensure normal ventilation and heat dissipation. Avoid installing instruments such as tape recorders, radio communication equipment, centrifuges, etc. near noisy equipment. Avoid installing instruments near computer monitors that are affected by electronic noise. Instruments cannot be installed in places where chemicals are stored and gases are generated.

Primary placement in Spain; available across 1 country total.

Trade name

Automatic fluorescence microscopic image scanning analyzer

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.

06977698400433

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.

697769840GKPD07976

Reference / catalog number

GKPD079

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.

IVDR Class A

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The analyzer employs a detection method that combines fluorescence microscopy and image scanning. After the sample is stained with a fluorescent dye, it is excited by a light source, causing the cells to emit specific fluorescence. The optical microscope system and image scanning system capture these images, producing clear, magnified fluorescence microscopic images. This facilitates doctors in detecting and accurately identifying fungi, trichomonads, clue cells, or mycobacteria in the sample. Additionally, under the control of a microcontroller, the motor performs various actions, enabling automated operation

Additional information URL

http://www.guoke-medical.com/static/upload/file/20260324/1774318395510489.pdf

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.

• W0299IVD INSTRUMENTS - OTHER

• IVDR Class A medical devices in EUDAMED

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