57005-030

Organization name

Qufora A/S

SRN

DK-MF-000007943

Manufacturer status

Active

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

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 11 countries total.

• 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