EUDAMED last updated this device on Sep 7, 2026

Control For Insulin

B-16974969791228

On the marketIVDD — General

Applicable legislation: —
Organization name: Chongqing iSIA BIO-Technology 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 →: 16974969791228
Reference / catalog number: 095Z

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.

Control For Insulin is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Chongqing iSIA BIO-Technology Co., Ltd.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: Control For Insulin
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 →: 16974969791228
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-16974969791228
Reference / catalog number: 095Z
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 product is intended for in vitro diagnostic use, in the quality control of the accuracy of Immunoassays on clinical chemistry systems. This product can be used to monitor the control of accuracy or the control of repeatability of immunoassays. Control For QDs Immunofluorescence Assay."
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)16974969791228

EMDN nomenclature code(s)

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

W0102152008CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES

Critical warnings

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

Consult instructions for use

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

Control For Insulin

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Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

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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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Manufacturer information

Certificates

Certificates covering this device

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