Organization name

FOSHAN SAFETY MEDICAL EQUIPMENT CO.,LTD

SRN

CN-MF-000013172

Manufacturer status

Active

Primary placement in Spain; available across 32 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.

06974416450220

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.

697441645M5A00195

Reference / catalog number

321

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

Dental Unit is a mains electricity device designed to support a patient in a seated position to facilitate dental examination, treatment, and minor surgery procedures with air and water supply to other handpiece, provide strong and weak suction, three-way syringe spray, dental light and cuspidor. It is typically adjustable in height to enable healthcare staff to perform procedures while standing, and for used in hospital stomatology or dental clinics.

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.

• Q0199ODONTOLOGY DEVICES - OTHER

• Class IIa medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.