Organization name

HLB Life Science Co., LTD

SRN

KR-MF-000031817

Manufacturer status

Active

Primary placement in Spain; available across 32 countries total.

Trade name

Fixed Volume Dropper 600ul

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.

08809899621776

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.

880989962CBT26RD

Reference / catalog number

HLB-FVD600UL-25EA

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 A

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

23

Additional product description

Disposable dropper to collect capillary blood specimen for in-vitro diagnostic testing

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.

• W0501010203BLOOD COLLECTION, CAPILLARY TUBES

• IVDR Class A medical devices in EUDAMED

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