- New
Plinest Eye – 2ml polynucleotide gel for the eye area
Plinest Eye is a:
- CE-certified medical device (sterile gel)
- Contains highly purified polynucleotides (HPT™ technology)
- Developed for intradermal use in the periocular area
- Aesthetically supports skin structure through hydrating and structural properties
- Specifically formulated for the delicate eye area
- For use by authorised medical professionals only
- Not intended for self-administration
Content: 1 × 2 ml syringe
Responsible economic operator according to GPSR:
Mastelli S.r.l.
Via Bussana Vecchia, 32
18038 Sanremo (IM)
Italy
+39 0184 511 522
info@mastelli.it
Product Safety – Summary (based on manufacturer information / MDR)
Product name: Plinest Eye
Manufacturer: Mastelli S.r.l., Via Bussana Vecchia 32, 18038 Sanremo (IM), Italy
CE marking: CE 0373
Product classification: Medical device
Intended use: Intradermal administration in the periocular area by authorised healthcare professionals
Contents: 1× 2 ml sterile prefilled syringe + two 30G ½ needles (Becton Dickinson, CE 0318)
Sterilisation method: EO
CH and UK representatives: As indicated on the product label (e.g., Emergo Consulting UK)
1. Safety and risk information
The product is certified under the MDR.
All safety-relevant details are taken from the manufacturer’s labelling.
The label includes:
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EO sterile
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Single-use
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Temperature limits
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Medical device symbol
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Batch and reference numbers
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General warning symbol
2. Intended user group
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Use restricted to authorised medical professionals
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Not intended for consumer use
3. Storage conditions
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2–25 °C
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Protect from light and moisture
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Do not freeze
4. Traceability / UDI
UDI data and REF numbers ensure full traceability in line with MDR requirements.
5. Disposal
Dispose of according to medical waste regulations (sharps / contaminated waste).
Do not dispose of in household waste.
6. Supplied needles
Becton Dickinson 30G ½, CE 0318, EO sterile, single-use.