C-K JECT

Organization name

C-K DENTAL IND.CO.,LTD.

SRN

KR-MF-000022929

Manufacturer status

Active

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

• CW009

  Do not reuse, risk of patient cross-infection

Primary placement in Bulgaria; available across 10 countries total.

Trade name

C-K JECT

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.

08800044506368

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.

88000445DN25314T

Reference / catalog number

27-25-M

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

100

Additional product description

27G X 25mm (0.4 X 25mm), Metric / Sterile dental injection needles for single use which are used in dental cartridge syringe for injection of dental local anaesthetics.

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.

• A010601CARPULE NEEDLES

• Class IIa medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.