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.

Placed on the market in Germany; per-country availability dates not published.

Trade name

Activated Partial Thromboplastin Time Assay Kit (Coagulation 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.

06976117451018

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-06976117451018

Reference / catalog number

NX-0001-09

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.

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC 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.

• W0103020102ACTIVATED PARTIAL THROMBOPLASTIN TIME

• IVDD — General medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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