Plenhyage XL Strong 1x2ml
Important Notice
Regulated medical device (EU MDR 2017/745). For sale exclusively to qualified healthcare professionals.
What this purchase includes
- Original productFrom the manufacturer or an official distributor, CE marked.
- Batch and expiry documentedRecorded per unit on the delivery note and the invoice.
- Controlled storageOur own Madrid warehouse, 12 to 18 °C under 24 h control.
- Dispatch in 24 to 48 hFrom Madrid, insured and with a tracking number.
- Reachable Monday to Friday9:00 to 17:00 by WhatsApp and email. People, not forms.
Plenhyage® XL Strong is the highest concentration in the Plenhyage XL range from Bioformula S.r.l. (Italy): high-molecular-weight polynucleotides at 2.5 %, of fish origin, in a 2 ml pre-filled syringe for dermal application. It is a biostimulator, not a filler: it provides neither volume nor projection.
- Polynucleotides 2.5 %
- Manufacturer Bioformula S.r.l.
- Contents 1 syringe × 2 ml
- Needles 2 × 30G ½"
- Plane dermal
Composition and technology
- High-molecular-weight polynucleotides: 2.5 %, the highest of the three concentrations in the Plenhyage XL range.
- Origin: highly purified DNA of fish origin. Nucleic acid fragments in a sterile solution in gel form.
- Mechanism of action: the polynucleotide chains bind water molecules and create favourable conditions for fibroblast activity, with a hydrating and antioxidant effect against free radicals, as well as promoting cell renewal and the quality of the dermis.
- The formulation contains neither hyaluronic acid nor anaesthetic.
The Plenhyage XL range
| Plenhyage XL Thin | Polynucleotides 1 % — 1 syringe of 2 ml. Thin skin and delicate areas |
|---|---|
| Plenhyage XL Medium | Polynucleotides 2 % — 1 syringe of 2 ml. Intermediate concentration |
| Plenhyage XL Strong | Polynucleotides 2.5 % — 1 syringe of 2 ml. Maximum concentration, more intensive regeneration |
The three variants differ solely in the concentration of polynucleotides.
Relationship with the Mastelli range (Plinest / Newest)
Plenhyage XL is not part of the Mastelli family. It is a proprietary brand of Bioformula S.r.l. and does not use PN-HPT® technology (Polynucleotides High Purification Technology), which is a registered and patented trademark of Mastelli S.r.l. Both ranges are based on polynucleotides of fish origin, but they correspond to different manufacturers, purification processes and regulatory dossiers. The following table serves as a reference for comparing concentrations:
| Plinest (Mastelli) | PN-HPT® 20 mg/ml (2 %) — 1 syringe of 2 ml |
|---|---|
| Plinest Fast (Mastelli) | PN-HPT® 7.5 mg/ml — 1 syringe of 2 ml |
| Plinest Eye (Mastelli) | PN-HPT® 7.5 mg/ml — 1 syringe of 2 ml, eye contour |
| Plinest Hair (Mastelli) | PN-HPT® 7.5 mg/ml — 1 syringe of 2 ml, scalp |
| Plinest One (Mastelli) | PN-HPT® 2 mg/ml — 5 vials of 4 ml, large surfaces |
| Newest (Mastelli) | PN-HPT® 10 mg/ml + non-cross-linked HA 10 mg/ml + mannitol — 1 syringe of 2 ml |
| Newest One (Mastelli) | PN-HPT® + non-cross-linked HA + mannitol — 5 vials of 4 ml |
| Ialest (Mastelli) | Non-cross-linked HA 20 mg/ml (2 %), without polynucleotides — 1 syringe of 2 ml |
| Plenhyage XL Strong (Bioformula) | Polynucleotides 2.5 % — 1 syringe of 2 ml |
Indications and treatment areas
- Photoageing and sun damage
- Loss of skin elasticity and firmness
- Acne scars
- Dehydrated skin with irregular texture
Areas: face, neck, décolletage and other areas with loss of skin quality.
Technique and treatment protocol
- Injection plane: dermis.
- Technique: microdeposits (multiple puncture) or linear retrograde threading with a needle, according to the area.
- Needle: 30G ½" (13 mm); 2 units included.
- Dose and number of sessions: the manufacturer does not publish a fixed protocol of sessions and intervals for this reference. Follow the protocol indicated in the instructions for use on the pack and the clinician's judgement.
Technical data
| Manufacturer / brand | Bioformula S.r.l., Italy — not a Mastelli product |
|---|---|
| Active substance | High-molecular-weight polynucleotides 2.5 % |
| Origin of the active substance | Highly purified DNA of fish origin |
| Presentation | 1 pre-filled syringe of 2.0 ml, sterile and ready for use |
| Needles | 2 × 30G ½" (13 mm) |
| Route of administration | Injectable — dermal |
| Classification | Class III medical device with CE marking |
| Use | Qualified healthcare professionals only |
Storage and pack contents
- Storage: between 2 °C and 25 °C, protected from direct sunlight and heat sources. Do not freeze.
- Do not use after the expiry date shown on the pack.
- Sterile single-use product. Do not reuse or re-sterilise.
- The pack contains: 1 pre-filled syringe of 2 ml, 2 needles 30G ½", instructions for use and traceability labels.
Contraindications and warnings
Known hypersensitivity to any of the components; pregnancy and breastfeeding; active autoimmune diseases; active skin infection or inflammation in the treatment area, including active herpes simplex; coagulation disorders or anticoagulant therapy; ongoing oncological treatment; patients under 18 years of age.
As this is a product of fish origin, assess any history of fish allergy before application.
Always consult the instructions for use included in the pack before application. The binding contraindications are those set out in the official documentation accompanying the product.
Medical device intended exclusively for qualified healthcare professionals. Technical information based on the documentation of the Plenhyage® brand (Bioformula S.r.l.). This data sheet does not replace the instructions for use accompanying the product.