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EUDAMED last updated this device on Jul 14, 2026
69332898CE5100F8Automatic Glycohemoglobin Analyzer is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Guangzhou Wondfo Biotech Co., Ltd.. Placed on the EU market in Romania. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06933289831673WK02(01)06933289831673
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0201050201HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS3 warnings recorded — scroll inside the panel to see all entries.
The analyzer must be used under good grounding conditions Incorrect grounding may cause electric shock and damage to the analyzer. Before turning on the analyzer, please confirm that the output voltage of the power junction box meets the requirements of the analyzer and that a suitable fuse or circuit breaker has been installed. Do not touch the power supply, buttons and screen with wet hands as you may get an electric shock.
The analyzer must be operated within the specified ambient and humidity temperature range, otherwise the results may be unreliable.It is prohibited to install by personnel who have not been trained or authorized by Wondfo Company, otherwise it may cause injury or damage to the analyzer. Do not touch the moving parts, and the head, hands, clothes, etc. must be kept at a safe distance from the moving. Do not use cleaners or disinfectants that chemically react with the analyzer components or materials contained in the analyzer to cause danger. If hazardous substances leak on the surface or enter the inside of the instrument, appropriate disinfection should be taken. Before cleaning, please make sure that the instrument is powered off.
All items (samples, controls, calibrators, reagents, waste liquid, etc.) and areas of contact with these substances are potentially bio-infectious. Operators in the laboratory contact with related items and areas, should comply with laboratory safety regulations, and wear personal protective equipment(such as laboratory protective clothing, gloves, etc.). The sampling needle is relatively sharp, and the blood samples, quality controls and calibrators that may be carried on the sampling needle are potentially contagious, so avoid contacting with the sampling needle.
CN-MF-000000689The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Romania; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| RomaniaPrimary placement | — | Still on market |
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.
View in glossary →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.
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 →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 →Certificate health across this manufacturer's portfolio.
V76 058008 0046SupplementedV76 058008 0045SupplementedV76 058008 0048IssuedNotified 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 →Notified 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 →Notified 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 →No certificate specifically references this device's Basic UDI-DI.