Organization name

Liaoning Upcera Co Ltd

SRN

CN-MF-000013088

Manufacturer status

Active

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

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

• CW011

  Federal Law restricts this device to sale by or on the order of a dentist.
• CW999

  Safety instruction: 1. Please use this product strictly in accordance with the product instruction manual and do not use it on occasions other than those specified in the product instruction manual. 2. During the processing of this product, please use protective glasses, a dust collection device and an effective breathing mask to avoid inhaling dust. 3. When this product is cracked or defective, please wear protective gloves to avoid scratches on your hands. 4. This product should be made and used by relevant dental professionals. 5. If hypersensitive to acrylic resin materials, great caution must be taken when using this product. 6.This product should be placed out of the reach of children.

Primary placement in Germany; available across 27 countries total.

Trade name

not provided

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.

06942480715095

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.

694138229912HG

Reference / catalog number

/

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

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

Status

On the market

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.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• Q01010199DENTAL RESTORATION DEVICES - OTHER

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.