57003-015

Organization name

Qufora A/S

SRN

DK-MF-000007943

Manufacturer status

Active

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

• CW010

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

  EUDAMED did not publish a description for this code.
• CW135

  EUDAMED did not publish a description for this code.
• CW011

  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. Since the list is not exhaustive a healthcare professional should always consider individual patient factors as well.
• CW337

  Transanal/rectal irrigation can be associated with passing sensations of bowel discomfort, nausea, shivering, fatigue, sweating, headache and light bleeding from the rectum. Please contact your healthcare professional for further advice.

Primary placement in Denmark; available across 8 countries total.

Trade name

not provided

UDI-DI code

05710187015043

Basic UDI-DI

5710187QUFMINIGORW

Reference / catalog number

57003-015

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

Transanal Irrigation

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.

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