Organization name

Hangzhou Singclean Medical Products Co., Ltd.

SRN

CN-MF-000014098

Manufacturer status

Active

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

• CW999

  The product must not be used in pregnant or breast-feeding women or children.

Primary placement in France; available across 27 countries total.

Trade name

Pretthyal®

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.

06936020160353

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-06936020160353

Reference / catalog number

DF-PH1-20-1.0

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 III

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The product is intended to be used for facial tissue augmentation. It is recommended to be used for the correction of wrinkles and for lip enhancement after accidents and trauma.

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.

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES

• Class III medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.