Organization name

Poly Medicure Limited

SRN

IN-MF-000043009

Manufacturer status

Active

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

• Caution

  Refer IFU

Primary placement in Austria; available across 32 countries total.

Trade name

Transfusion Sets (BT Set)

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.

08902095701126

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.

890209570091FV

Reference / catalog number

70112

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

1

Additional product description

BT SET WITH AIRVENT 150 CMS TUBE WITH FILTER, LUER SLIP, LATEX BULB, WITH NEEDLE, PAPER PACK

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.

• A03010102INFUSION CONTROLLERS WITH FILTER (ALSO TRANSFUSION CONTROLLERS)

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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