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.

• The product cannot replace the conventional suture when used for spurting hemorrhage. The product cannot replace the delicate operation procedures, rational binding and other conventional hemostatic methods. The product is aseptic, and therefore cannot be re-sterilized. The unused product with their packages opened cannot be reused. Reuse of the product may lead to patient infection and/or hemostasis failure. Do not inject or place the product into blood vessels as potential for embolization and death may exist. The product is not recommended for use with autologous blood salvage circuits, because there may be a risk of some small particles entering into blood and causing embolism.

  OTHER

Primary placement in Austria; available across 27 countries total.

Trade name

Quickclean®

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.

06936020106436

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.

69360201248S

Reference / catalog number

MPH-QC-3.0

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

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.

• M040599HAEMOSTATIC DRESSINGS - OTHER

• Class III medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.