EUDAMED last updated this device on May 8, 2026

KEYU Formed Element Analysis Calibrator

B-06974735361900

On the marketIVDD — General

Applicable legislation: —
Organization name: Zhuhai Keyu Biological Engineering Co., Ltd
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 →: 06974735361900
Reference / catalog number: SED-CAL-1

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

KEYU Formed Element Analysis Calibrator is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Zhuhai Keyu Biological Engineering Co., Ltd. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: KEYU Formed Element Analysis Calibrator
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 →: 06974735361900
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 →: B-06974735361900
Reference / catalog number: SED-CAL-1
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 →: GS1

Classification

Risk category: IVDD — General
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: This Formed Element Analysis Calibrator is used for calibration of Urine Sediment Analyzer, Automatic Urine Analysis System and Feces Analyzer.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)06974735361900

EMDN nomenclature code(s)

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

W0101050302CALIBRATORS SINGLE COMPONENT (CC)

Critical warnings

No critical warnings reported for this device.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	—	Still on market

KEYU Formed Element Analysis Calibrator

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

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Market distribution

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Manufacturer information

Certificates covering this device

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Certificates