Organization name

RDA Spot, UAB

SRN

LT-MF-000027300

Manufacturer status

Active

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

• Consult instructions for use
• Do not use if package is damaged
• Do not use past indicated date
• Do not re-use

Primary placement in Lithuania; available across 32 countries total.

Trade name

IVD Sample Collection Device

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.

04779054721228

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.

477905472RS26003KJ

Reference / catalog number

HMX-RDA-WB10

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

1

Additional product description

An IVD sample collection device intended for collecting samples and transport them to the laboratory.

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.

• W0501010299CAPILLARY BLOOD COLLECTION DEVICES - OTHER

• IVDR Class A medical devices in EUDAMED

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