Organization name

Gansu Constar Technology Group Co., Ltd.

SRN

CN-MF-000041579

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 12 countries total.

Trade name

Amaia

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.

06942671500677

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.

B-06942671500677

Reference / catalog number

MCK1

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 IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

- soft contact lens are daily wear lenses for myopia correction in patients without contraindications. - total diameter:14.20mm - base curve radius:8.40mm to 8.80mm

Additional information URL

No additional information URL provided by the manufacturer.

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.

• Q0210040102CONTACT LENSES - HYDROGEL, REUSABLE

• Class IIa medical devices in EUDAMED

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