EUDAMED last updated this device on Jul 2, 2026

Sinocare iCan

6934175005A0007PZ

On the marketClass IIb

Applicable legislation: —
Organization name: Changsha Sinocare Inc.
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 →: 06934175023936
Reference / catalog number: N/A

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.

Sinocare iCan is an EU-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Changsha Sinocare Inc.. Placed on the EU market in Slovakia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: Sinocare iCan
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 →: 06934175023936
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 →: 6934175005A0007PZ
Reference / catalog number: N/A
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: Class IIb
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: —
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)06934175023936

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

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

Z1204011502INVASIVE BLOOD SUGAR MONITORING SYSTEMS

Critical warnings

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

Consult instructions for use
Before you use the iCan i3 Continuous Glucose Monitoring (CGM) System, read the instructions included in the Instruction for Use. The Instruction for Use includes important safety information, and instructions for use. Discuss with your healthcare professional about how you should use the information from your iCan i3 CGM to help manage your diabetes.Failure to use the iCan i3 CGM System and its components according to the instructions for use and all indications, contraindications, warnings, precautions, and cautions may result in you missing a severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) occurrence and/or making a treatment decision that may result in injury.
Do not use if package is damaged
Do not use sensor if its sterile package has been damaged or opened, because it might cause an infection.
MR UNSAFE
Do not wear your iCan i3 CGM (sensor, transmitter, receiver, or mobile device) for magnetic resonance imaging (MRI), computed tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. The iCan i3 CGM has not been tested in those situations. The magnetic fields and heat could damage the components of the iCan i3 CGM, which may cause it to display inaccurate sensor glucose results or may prevent alerts. Without iCan i3 CGM results or alert notifications, you might miss a severe low or high glucose event.
Type BF applied part
Do not use past indicated date
Check expiration date on Sensor Pack. Do not use if expired. Do not use if Transmitter has expired.
Do not use the iCan i3 CGM if you are pregnant, on dialysis, implanted with a pacemakers or critically ill. It is not known how different conditions or medications common to these populations may affect performance of the system. iCan i3 CGM results may be inaccurate in these populations. Do not use iCan i3 CGM, if you are suffering from coagulation disorders or taking anticoagulant drugs.
OTHER
Do not re-use
The CGM system is designed for single use. Reuse may cause no glucose results and infection.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Slovakia; available across 1 country total.

Country	On market since	Until
SlovakiaPrimary placement	Jul 2, 2025	Sep 27, 2028

Sinocare iCan

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI 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

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

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Manufacturer information

Certificates

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Certificates covering this device