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dicoTUBER Tuberculin Syringe with Needle, 1 ml, 0.45 × 13 mm, Sterile
Description
The dicoTUBER tuberculin syringe is a sterile single-use syringe with a pre-fitted 0.45 × 13 mm needle, intended for precise intradermal drawing up and administering of medicinal products and liquids, and for performing the intradermal tuberculin test.
The 0.01 ml scale allows exact dosing, and the special plunger design reduces the residual volume left in the syringe.
Main features
- Complete with pre-fitted 26 G, 0.45 × 13 mm needle
- Syringe made entirely of polypropylene
- Contrasting white plunger
- Transparent barrel for full visual control of the contents
- Luer-type conical tip
- Smooth plunger movement thanks to a rubber seal
- Restrictive collar prevents accidental plunger retraction
- Clear, legible and durable black scale with 0.01 ml graduation
- Special plunger design reduces residual volume
- Syringe name and manufacturer's logo printed on the barrel
- Capacity 1 ml
- Pyrogen-free, non-toxic
- Latex-free and phthalate-free
- Single-use, sterilised with ethylene oxide
Application
Precise intradermal drawing up and administering of medicinal products and liquids. Intradermal tuberculin (Mantoux) test.
Certificates and standards
- Class IIa medical device, rule 6 (Annex IX of Directive 93/42/EEC)
- Notified body: TÜV Rheinland LGA Products GmbH
- EC Certificate No. DD 1023663-1
- Declaration of conformity issued 02.02.2026, technical file TD-41
- Manufacturer quality system: EN ISO 13485, ISO 9001
- Biological evaluation to the EN ISO 10993 series; risk management to EN ISO 14971
- Packaging compliant with Regulation (EU) 2025/40 (PPWR)
No instructions for use are supplied — the manufacturer has declared this low-risk device can be safely used without them (Annex I, Chapter II, point 13.1 of Directive 93/42/EEC).
Packaging
- Individual packaging: blister pack
- Sales packaging: 100 pcs
- Transport packaging: 32 × 100 pcs
- REF: TU-U20-1-BL
- Manufacturer: ZARYS International sp. z o.o., Ziemska 44, 41-803 Zabrze, Poland