Organization name

LimFlow SA

SRN

FR-MF-000011529

Manufacturer status

Active

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

• The use of the device should be limited to those specialists trained to perform the procedures for which this device is intended.

  OTHER

• The device should not be used without firstreading and understanding these directions in their entirety.

  OTHER

• The Stent Graft System is designed and intended for single use only. Do not autoclave, reshape, re-sterilize or reuse. Exposure to high heat may cause changes to the functionality of the device. Reuse, even if re-sterilized, can compromise the Stent Graft System performance characteristics and may cause infection.

  OTHER

• Do not use organic solvents (e.g. alcohol) withthe delivery system.

  OTHER

• Use inpatients with concomitant hepatic insufficiency has not been evaluated.

  OTHER

• Use in pregnant and breastfeeding women has not been evaluated.

  OTHER

• Long-term outcomes in patients with renal insufficiency have not been evaluated.

  OTHER

• Contraindicated in patients with deep venous thrombus in target vein.

  OTHER

• Contraindicated in patients with uncorrected bleeding disorders or patients who cannot receive anticoagulation or antiplatelet aggregation therapy.

  OTHER

• Contraindicated in patients with a poor cardiac output, because an AV fistula may increase the risk for cardiac decompensation.

  OTHER

• Contraindicated in neonate and pediatric patients.

  OTHER

• MRI Conditional.

  OTHER

Primary placement in Germany; available across 12 countries total.

Trade name

LimFlow Stent Graft System

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.

00850017630536

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.

0850017630RGSDDLLLCE24RT

Reference / catalog number

RGS-55200-CE-24

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 IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

200 mm Extension Stent, Thumwheel delivery mechanism

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• Stent Diameter
• Stent length

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

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

• P0704020299PERIPHERAL VASCULAR STENTS - OTHER

• Class IIb medical devices in EUDAMED

• 1000261596Issued
  Quality management systemNotified body: DQS Medizinprodukte GmbH (0297)Expiry: Oct 26, 2028
• 1000261582Issued
  Technical documentationNotified body: DQS Medizinprodukte GmbH (0297)Expiry: Nov 27, 2028

Certificate health across this manufacturer's portfolio.