Organization name

Intensiv Medical Products IMPROMEDIFORM GmbH

SRN

DE-MF-000014610

Manufacturer status

Active

Primary placement in Germany; available across 30 countries total.

Trade name

not provided

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.

04049051090802

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.

4049051A03020101EXXXXXXQA

Reference / catalog number

M19130

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

Infusion set with filter, injection site and clamp. | MDN: MDN 1202 | Sterilization method: Ethylene Oxide | Contraindications: see IFU

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

2 packaging levels registered — each level carries its own UDI-DI.

• 04049051090802× 1 unitBase unit
  • 04049051090819× 50 units
  • 04049051090826× 150 units

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• A03020101LOW PRESSURE EXTENSION LINES

• Class IIa medical devices in EUDAMED

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