Certification and approval
DermoRegen PRP tubes meet the most stringent requirements.
CE Class 4: what it means for the clinic
CE Class 4 is the highest risk class for medical devices in the EU/EEA, reserved for products that come into direct contact with blood and internal organs. The classification entails the strictest requirements for documentation, clinical evaluation, production control, and post-market surveillance.
DermoRegen PRP tubes are approved under EU MDR (Medical Device Regulation) and by the Norwegian Directorate for Medical Devices. For the clinic this means full legal and regulatory safety, and a convincing argument for patients who ask about product quality and safety.
- CE Class 4, EU certification: highest risk class for medical devices. Requires the strictest clinical and technical documentation requirements in the EU/EEA.
- MDR-approved, EU MDR 2017/745: approved under the EU Medical Device Regulation, the most demanding standard for medical devices in Europe.
- Norwegian approval, Directorate for Medical Devices: approved by Norwegian health authorities. Full regulatory safety for Norwegian clinics.
Areas of use
Suitable for a wide range of clinical indications.
- Skin improvement and biostimulation: PRP stimulates collagen production and the skin's own repair processes for visible rejuvenation and improved skin quality.
- PRP treatment for hair loss: well-established and documented indication. PRP injected into the scalp stimulates hair follicles and promotes hair growth.
- Combination with microneedling, mesotherapy, and exosomes: PRP is used as a booster in combined treatment protocols for enhanced biological response and faster recovery.
- Wound healing and post-laser regeneration: accelerates healing after invasive procedures and laser, reducing downtime and promoting more even recovery.
Technical properties
Separation gel and anticoagulant: why it matters.
- Separation gel: the gel forms a physical barrier between plasma and erythrocytes during centrifugation. This ensures clean and contamination-free separation of platelet-rich plasma, for consistent and reproducible treatment results.
- Anticoagulant: prevents blood from coagulating in the tube during treatment and centrifugation. Ensures that platelets remain intact and biologically active until application, which is critical for PRP quality.
- Vacuum-sealed: vacuum technology ensures correct blood volume at sampling and maintains a sterile, closed system from sampling to centrifugation, in line with CE Class 4 requirements.
- Centrifuge compatibility: DermoRegen PRP tubes are designed for compatibility with most clinic centrifuges, no specially adapted equipment required. Standard centrifugation protocols give high PRP concentration and low contamination risk.
Technical specifications: DermoRegen PRP tubes
- Package contents: 6 tubes of 10 ml.
- Volume per tube: 10 ml (vacuum).
- Additives: separation gel and anticoagulant.
- Sealing technology: vacuum-sealed, sterile closed system.
- Classification: CE Class 4, single-use medical device.
- Regulatory approval: EU MDR 2017/745, Norwegian Directorate for Medical Devices.
- Centrifuge compatibility: most clinic centrifuges.
- Manufacturer: DermoRegen, Dermoaroma Italy SRL, Rome, Italy.
For the clinic: why choose DermoRegen PRP tubes?
- CE Class 4, highest standard: CE Class 4 and MDR approval is the strongest regulatory argument that exists for medical devices in Europe. A convincing safety signal toward patients and regulatory authorities.
- Norwegian government approval: approved by the Directorate for Medical Devices, ensuring full legal and regulatory safety for Norwegian clinics offering PRP treatments.
- Predictable and reproducible results: separation gel and anticoagulant ensure consistent PRP quality, giving the practitioner control over the result and patients confidence in what they can expect.
- Broad clinical applicability: skin rejuvenation, hair loss, combination treatments, and wound healing. One product covers the most important PRP indications in aesthetic and regenerative medicine.
DermoRegen PRP tubes are the regulatorily safest choice for PRP treatments in Norwegian clinics. CE Class 4, MDR-approved, and approved by the Directorate for Medical Devices, produced in Italy by Dermoaroma, with separation gel and anticoagulant for high PRP concentration and consistent results.
