CE certified Class IIb medical device under EU Directive 93/42/EEC for preparation of autologous platelet Rich plasma.
US FDA 510(k) cleared (K110035) as a Class II medical device for the rapid and safe preparation of autologous PRP for mixing with bone grafts in orthopedic applications.
Manufactured under ISO 13485–compliant quality management system and GMP Level quality controls.
CE certified Class IIb medical device under EU Directive 93/42/EEC for preparation of autologous platelet Rich plasma.
US FDA 510(k) cleared (K110035) as a Class II medical device for the rapid and safe preparation of autologous PRP for mixing with bone grafts in orthopedic applications.
Manufactured under ISO 13485–compliant quality management system and GMP Level quality controls.
Biocompatibility, sterility, shelf Life and environmental control testing performed in line with international medical device standards.
Autologous PRP vacuum tube system (22 mL)
Description
Cellenis PRP 22ml is a sterile, single-use, autologous platelet-rich plasma (PRP) preparation tube system designed to collect a small volume of the patient’s blood and, after centrifugation, yield a highly purified PRP fraction with minimal red blood cell and neutrophil content. The 22 mL vacuum tube incorporates a patented separator gel and a proprietary anticoagulant coating to optimize platelet recovery and maintain a physiological pH. Once processed according to the instructions for use, the resulting PRP can be used by trained healthcare professionals for a range of regenerative and aesthetic indications, including skin rejuvenation and hair restoration.
Bnefits
Enables rapid, simple preparation of autologous PRP at the point of care using a single-spin protocol.
High platelet recovery (around 80% ±10%) from the initial whole blood sample, helping achieve an optimal and consistent platelet concentration.
Patented separator gel technology removes virtually all red blood cells and the majority of neutrophils, reducing pro-inflammatory components in the final PRP.
Maintains PRP at a physiological pH to support patient comfort during treatment.
Closed, sterile vacuum system designed to minimize contamination risk and improve reproducibility of PRP preparation.
High PRP yield per tube, with the 22 mL tube generating approximately 13 mL of PRP, offering favourable cost per millilitre.
Compatible with standard medical centrifuges using a single, short centrifugation cycle (about 10 minutes).
Autologous system using the patient’s own blood, non-allergenic and suitable for a wide range of skin types when used appropriately.
Supported by CE Class IIb certification and FDA 510(k) clearance (for PRP preparation for mixing with bone graft), and manufactured under ISO 13485 quality standards.
Indications
Preparation of autologous platelet-rich plasma (PRP) from whole blood for use in approved medical and aesthetic procedures.
Aesthetic and dermatologic applications such as improving skin texture and tone, supporting treatment of sun-damaged or photo-aged skin, and reducing the appearance of fine lines and certain types of scars when used as part of a complete treatment protocol.
Biocompatibility, sterility, shelf Life and environmental control testing performed in line with international medical device standards.
Adjunctive treatment in hair restoration protocols to support hair density and scalp condition when PRP is applied by qualified professionals.
Use in other medical specialties where autologous PRP is indicated and compatible with the regulatory status of the device (e.g., in Europe as a CE Class IIb PRP device and in the US for FDA-cleared orthopedic/bone graft mixing indications).
Composition
Internally coated glass vacuum collection tube (22 mL nominal fill volume) designed to reduce platelet adhesion to the tube wall.
Proprietary modified anticoagulant coating on the inner tube surface to reduce acidity, support platelet metabolism and improve patient comfort.
Patented separator gel formulated to recover approximately 80% of platelets while removing about 99.9% of red blood cells and 92–96% of neutrophils during centrifugation.
Sterile rubber stopper and closure compatible with standard blood collection and centrifugation equipment.
PRP contents after processing consist of autologous platelets suspended in plasma with minimal red blood cells and a controlled proportion of mononuclear cells.
Formulation
Class IIb sterile medical device (PRP preparation tube) containing a separator gel and anticoagulant; no added biologically active pharmaceutical ingredients.
Single-use autologous blood processing system intended for preparation, not storage, of PRP.
Packaging
Single-use, sterile 22 mL vacuum PRP tube supplied individually (tube only) or within a patient kit depending on distributor configuration.
Tubing and components are supplied sterile and non-pyrogenic, for single patient use only and to be discarded after use.
Outer packaging designed to protect the glass tube from impact and environmental exposure until point of use.
Usage
Use only by appropriately trained healthcare professionals familiar with PRP procedures and local regulations.
Verify integrity of the packaging, expiry date and tube labelling before use; do not use damaged or expired tubes.
Collect the required volume of the patient’s venous blood directly into the 22 mL Cellenis PRP vacuum tube according to the instructions for use (IFU) and using appropriate venipuncture technique.
Place the filled tube in a compatible, properly balanced centrifuge and spin according to the manufacturer’s recommended settings (single spin of approximately 10 minutes at the specified g-force).
After centrifugation, remove platelet-poor plasma from the upper layer if a higher platelet concentration is desired, leaving the platelet-rich layer above the separator gel.
Gently resuspend the platelets in the remaining plasma by inverting or agitating the tube as instructed in the IFU to obtain homogeneous PRP.
Withdraw the prepared PRP into sterile syringes using the recommended needle or transfer device, maintaining aseptic technique throughout.
Apply or inject the PRP only in accordance with the relevant clinical protocol and local regulatory approvals for the intended indication.
Dispose of the used tube, needles and other sharps as clinical waste in accordance with institutional and national guidelines; do not reuse the tube or accessories.
Contraindications
Contraindicated in patients with known blood or coagulation disorders where venipuncture or PRP preparation is unsuitable, as per clinical judgement and local guidelines.
Patients with active systemic infection, sepsis or local infection/inflammation at the intended treatment site.
Known autoimmune diseases or significant blood pathologies identified as contraindications for PRP in the Cellenis/Estar Medical FAQ.
Current or recent malignancy, particularly where growth-factor–rich autologous preparations are considered inappropriate, as outlined in manufacturer guidance.
Pregnancy and breastfeeding, which are listed as contraindications or situations requiring caution in the Cellenis PRP FAQ.
Known hypersensitivity or allergy to any component of the collection system (e.g., anticoagulant, dressings or ancillary materials).
Use in patients taking medications that significantly affect platelet function or coagulation (such as certain anticoagulants or high-dose NSAIDs) unless assessed and approved by the responsible physician.
Any other contraindications or exclusion criteria specified in the full instructions for use and in applicable local professional guidelines.
Adverse Effects
Local discomfort, pain or pressure at the venipuncture site or at the PRP application site.
Transient erythema, swelling and oedema at treated areas following PRP administration.
Bruising or haematoma formation associated with blood draw or injection, similar to other needle-based procedures.
Mild itching, tightness or transient sensitivity in the treated area.
Rare risk of infection, bleeding or tissue injury if aseptic technique is not strictly followed.
Very rare hypersensitivity or allergic-type reactions to ancillary materials (e.g., antiseptics, dressings or latex where present), rather than to the autologous PRP itself.
Any additional adverse effects described in the Cellenis PRP IFU should be monitored and managed according to standard clinical practice.
Storage Conditions
Store the unopened PRP tubes in their original packaging in a clean, dry environment at controlled room temperature as specified on the product labelling.
Protect from direct sunlight, excessive heat, frost and other extremes of temperature.
Do not freeze the tubes and do not expose them to temperatures outside the labelled storage range.
Keep out of reach of unauthorised personnel and ensure that only trained staff handle and prepare the device.
Use before the expiry date printed on the label; do not use damaged, dropped or visibly compromised tubes.
Single use only; never attempt to resterilize or reuse the tube.
Duration
Determined by the treating healthcare professional according to indication, patient characteristics and local clinical guidelines; the device itself is intended for single-use preparation of PRP in a single treatment session.
Onset
Onset and duration of clinical effect depend on the specific PRP treatment protocol and indication (e.g., skin rejuvenation or hair restoration) and are not specified as fixed values in the device\u2019s core technical documentation.
