Organization name

Guangdong Kindly Medical Device Group Co.,Ltd.

SRN

CN-MF-000006505

Manufacturer status

Active

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

• CW010

  The use of this product must meet the requirements of the relevant operating norms and relevant regulations of the medical department. It is limited to trained doctors, nursing staff and other professional medical personnel, and non-professional personnel are prohibited to use it.
• CW007

  If sterile packaging is damaged or accidentally opened, the scale is not clear or incomplete, there are foreign bodies or product damage, do not use.
• CW009

  This product is for one-time use only, and repeated use is prohibited.

Primary placement in Germany; available across 32 countries total.

Trade name

Single-use syringes

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.

16954152726763

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.

69541527202101sJZQ4E

Reference / catalog number

8300063470

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 I

Applicable legislation

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

Status

On the market

Quantity

100

Additional product description

3-Parts, 10mL(12mL), Luer Slip

Additional information URL

https://sms.gdkdlct.cn/en/0311276692.pdf

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.

• A020102010202INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE

• Class I medical devices in EUDAMED

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