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EUDAMED last updated this device on Jun 17, 2026
5710187QUFBALLKLICK1Q6Qufora IrriSedo Klick tube ML is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Qufora A/S. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0571018701644659050-0021 packaging level registered — each level carries its own UDI-DI.
05710187016446× 1 unitBase unit05710187016453× 4 units(01)05710187016446
European Medical Device Nomenclature — the EU product classification assigned to this device.
A03040299IRRIGATION KITS, SINGLE-USE - OTHER4 warnings recorded — scroll inside the panel to see all entries.
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
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 France; available across 3 countries total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | Jul 31, 2023 | Still on market |
| Denmark | Jul 31, 2023 | Still on market |
| Sweden | Jul 31, 2023 | Still on market |
DK-MF-000007943The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →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.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →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.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
5710187QUFBALLKLICK1Q6On the marketQufora IrriSedo Klick Base set ML5710187QUFBALLKLICK1Q6On the marketQufora IrriSedo Klick Teaching Set DE5710187QUFBALLKLICK1Q6On the marketQufora IrriSedo MiniGo accessoire set NL5710187QUFMINIGORWOn the marketQufora IrriSedo MiniGo accessory set ML5710187QUFMINIGORWOn the marketQufora IrriSedo MiniGo DE5710187QUFMINIGORWOn the marketNo certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.