Organization name

Changsha Sinocare Inc.

SRN

CN-MF-000012244

Manufacturer status

Active

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

• CW011

  Do not use the iCan view Glucose Data Reader & iCan when undergoing an MRI, CT Scan, or Diathermy treatment.

Primary placement in Germany; available across 12 countries total.

Trade name

Sinocare iCan® view Glucose Data Reader

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.

06934175001903

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.

6934175005A0003PR

Reference / catalog number

MDA 0204

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

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Sinocare iCan® view Glucose Data Reader is used to display iCan CGM glucose data sent from the transmitter. It also provides alerts based on the glucose settings you choose. Reader is used with iCan CGM only. The iCan CGM is a real time, continuous glucose monitoring device indicated for the management of diabetes for people age 2 years and older. It is intended to replace fingerstick blood glucose testing for diabetes treatment decisions.

Additional information URL

https://www.ican-cgm.com/

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.

• Z1204011502INVASIVE BLOOD SUGAR MONITORING SYSTEMS

• Class IIb medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.