59001-005

Organization name

Qufora A/S

SRN

DK-MF-000007943

Manufacturer status

Active

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

• 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.
• CW010

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

  EUDAMED did not publish a description for this code.
• 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

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Trade name

not provided

UDI-DI code

05710187014664

Basic UDI-DI

5710187QUFBALLKLICK1Q6

Reference / catalog number

59001-005

Issuing entity

GS1

Risk category

Class I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Transanale irrigation Introset, Ballonkatheter standard

Additional information URL

https://www.qufora.com/

Clinical sizes

• Standard

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

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

• G99GASTROINTESTINAL DEVICES - OTHER
• A99DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER