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.Avoid collision with hard material, avoid squeeze or shaking. 2.Don’t apply to patient before the material is fully sintered. 3.This product should only be handled by dental specialist. 4.Wear suitable face mask to prevent fine dust inhalation. Avoid fine dust air pollution by using the air blaster in short bursts only rather than a continuous flow.

Primary placement in France; 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.

06941382296305

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.

694138229986JD

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.