I-REMOVE Fat Binder with vitamins

Organization name

InQpharm Consumer Health GmbH

SRN

DE-MF-000008147

Manufacturer status

Active

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

• CW135

  EUDAMED did not publish a description for this code.
• CW010

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

  » if you are diabetic, as this product supports the management of food cravings by balancing blood glucose levels. Diabetic patients may have to adjust their daily anti-diabetic treatment to avoid hypoglycaemic attacks » if you use cholesterol-reducing medication » if any medical conditions exist
• CW999

  Not recommended for children under 12 years of age. The use of this product by children between 12 to 18 years of age is subject to the supervision of healthcare professionals
• CW999

  Do not take this product » if you are pregnant or breastfeeding » if your BMI (Body Mass Index) is below 18.5 » within two (2) hours of taking any fat-soluble medicines (e.g. oral contraceptive pills)
• CW999

  This product contains vitamin A or retinol. Do not take/please consult your healthcare professional » if you are pregnant or likely to become pregnant » if you eat liver or liver products once a week; or are taking other supplements containing retinol » if you are at risk of osteoporosis (postmenopausal women and elderly)
• CW999

  This product contains trace amounts of oxalic acids, which are found in many other green vegetables. If you have kidney disease or kidney stones, avoid taking this product on a regular basis
• CW999

  As this product contains fibres, it is recommended that you take at least eight (8) glasses of water a day to avoid any possibility of constipation or stomach discomfort. If any of these conditions persist, please consult your healthcare professional
• CW999

  The incidence of adverse side effects being reported was very rare (< 0.01%). These hypersensitivity reactions were typical of food allergies, like rash, itching, slight swelling and mild gastrointestinal upset. In such cases, treatment should be discontinued.

Primary placement in Germany; available across 1 country total.

Trade name

I-REMOVE Fat Binder with vitamins

UDI-DI code

D-DEMF000008147FBGVT4BFG

Basic UDI-DI

B-DEMF000008147FBGVT4BFG

Reference / catalog number

Type 4B

Issuing entity

EUDAMED

Risk category

Class IIb

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

An orally-administered device intended to facilitate weight loss and treat obesity through dietary fat binding and appetite control. It is designed to be swallowed immediately after meals to interact with dietary fats to form a large fat-fibre complex that is too large to be absorbed and is excreted by the gut. It also typically includes natural soluble fibre as an active ingredient that absorbs water and produces a bulking effect in the stomach creating a sensation of fullness and causing the user to eat less. It is available in tablet and powder sachet forms normally (non-prescription) over-the-counter (OTC) for use in the home or healthcare facility. This is a single-use device. This device is intended for long-term use. (Ref. GMDN: 56314)

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• G0402ORALLY ADMINISTERED DEVICES FOR APPETITE CONTROL AND REDUCTION OF INTESTINAL ABSORPTION

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