Organization name

Qufora A/S

SRN

DK-MF-000007943

Manufacturer status

Active

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

• CW011

  Contraindications: Known anal or colorectal stenosis, Colorectal cancer/pelvic malignancy pre surgical removal, Acute inflammatory bowel disease, Acute diverticulitis, Within 3 months of anal or colorectal surgery, Within 4 weeks of endoscopic polypectomy, Ischaemic colitis
• CW010

  EUDAMED did not publish a description for this code.
• CW030

  EUDAMED did not publish a description for this code.
• CW337

  Seek medical attention if the following is experienced during or after transanal/rectal irrigation: Sustained or severe bleeding from the rectum, Sustained or severe abdominal or back pain, with or without fever. Perforation of the bowel wall is extremely rare. However it is a serious and potentially fatal complication of transanal/rectal irrigation. Should this occur, immediate medical attention is required.

Primary placement in Denmark; available across 10 countries total.

Trade name

Qufora IrriSedo MiniGo teaching set ML

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.

05710187015241

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.

5710187QUFMINIGORW

Reference / catalog number

57001-105

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 I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Transanal Irrigation Teaching sæt

Additional information URL

https://www.qufora.com/

Clinical sizes

• Regular

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

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

• A03040299IRRIGATION KITS, SINGLE-USE - OTHER

• Class I medical devices in EUDAMED

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