Description

NOBAMED RUDAPLAST® 2.5cm x 9.14m Fixation Tape, White

RUDAPLAST® is a white fixation tape made of high-quality textile fabric coated with zinc oxide adhesive, ensuring excellent adhesive strength and secure fixation. Supplied on a roll with plastic discs on both sides, this tape is designed for fixing wound dressings, bandages, tubes, and catheters in medical, clinical, and first aid environments.

Intended Use

RUDAPLAST® is used for reliable fixation of wound pads, bandages, catheters, and tubing. It provides stable adhesion without causing skin irritation under normal use.

Application

• Unroll the tape to the desired length.
• Apply to clean, dry skin or over dressing material.
• Do not stretch the tape tightly, especially around limbs, to prevent circulation issues.
• Single-use only — discard after application.

Composition

• Base material: Viscose textile fabric
• Adhesive: Zinc oxide adhesive (colophonium-free)

Contraindications

• Do not use on fragile or damaged skin.
• Do not apply if allergic to zinc oxide or adhesive components.

Safety & Usage Notes

• To avoid swelling or circulatory disorders, do not apply under tension in a circular manner.
• Single-use medical device – reusing may lead to microbiological contamination or loss of adhesive performance.
• Store in a dry, dust-free place protected from sunlight.
• Usage time: up to 10 years after production.

Normative and Legal Compliance

RUDAPLAST® is classified as a medical product under both MDD 93/42/EEC and MDR (EU) 2017/745. It bears the CE mark and complies with DIN EN ISO 15223-1 and DIN EN 1041 standards for labeling and safety. The product is REACH compliant and contains no hazardous or toxic substances.

Packaging

• Primary packaging: folding box made of cellulose
• Secondary packaging: carton made of cellulose
• All packaging levels are marked with CE and standard-compliant labeling.

Incident Reporting

In accordance with MDR (EU) 2017/745, any serious incident related to this medical device must be reported to the manufacturer and the competent authority of the user’s Member State.

Disposal

Dispose of according to local regulations and infection control standards. Do not reuse or recycle contaminated materials.

Technical Specifications

Declarations of Conformity

• Declaration of Conformity (MDD 93/42/EEC)
• Declaration of Conformity (MDR 2017/745)

Glossary

• Zinc oxide adhesive: A medically safe adhesive with strong fixation and skin compatibility.
• REACH compliance: European regulation ensuring the product contains no toxic or environmentally harmful chemicals.
• MDR (EU) 2017/745: Regulation governing the safety and performance of medical devices sold within the EU.

About the Manufacturer

NOBAMED Paul Danz AG, founded in 1925 and based in Wetter (Ruhr), Germany, is a leading manufacturer of professional medical products. Certified under ISO 13485, the company produces a wide range of wound care, surgical, and disinfection products. NOBAMED is renowned for its innovation, safety, and sustainability, using environmentally conscious production methods and supporting humanitarian projects.

Manufacturer & Contact

© NOBAMED Paul Danz AG. Specifications may change without notice for product improvement.