C-Reactive Protein Reagent (Immunonephelometric Method)

Organization name

Shenzhen Dymind Biotechnology Co., Ltd.

SRN

CN-MF-000024842

Manufacturer status

Active

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

• CW011

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 1 country total.

Trade name

C-Reactive Protein Reagent (Immunonephelometric Method)

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.

06976117454101

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.

6970493090506007P5

Reference / catalog number

MY-0001-01

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

IVDR risk classes

IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.

IVDR Class C

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic 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.

• W01021109C-REACTIVE PROTEIN

• IVDR Class C medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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