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Identification number 0425 belongs to notified body ICIM S.p.A., which issued the underlying EC certificate.
PRP Tubes | Vi PRP-PRO (PU 2 pcs.)
Vi PRP-PRO PRP Tubes – Set of 2
Sterile PRP tube set for the professional preparation of platelet-rich plasma. Each borosilicate glass tube is designed for approximately 9 ml of blood and contains 0.8 ml of sodium citrate and a thixotropic separator gel.
- CE 0425, Class IIa medical device
- 2 sterile PRP tubes per sales unit
- Standard centrifugation: 1200 × g for 7 minutes
- For qualified healthcare professionals
- Suitable for professional PRP workflows, including orthopaedics, sports medicine, aesthetic medicine and hair medicine
Use must comply with the medical indication, the instructions for use and the facility’s internal procedures.
Small pack size for healthcare professionals
Vi PRP-PRO 2-pack: borosilicate glass PRP tubes with sodium citrate and separation gel
The Vi PRP-PRO 2-pack contains two sterile, CE-marked Class IIa PRP tubes for the professional preparation of platelet-rich plasma. Each vacuum tube is designed for approximately 9 ml of blood and contains 0.8 ml sodium citrate as anticoagulant together with a thixotropic separation gel. The standard centrifugation protocol is 1200 × g for 7 minutes.
2 tubesSterile PRP tubes per sales unit
CE 0425CE marking of the medical device
Class IIaClassification under Directive 93/42/EEC
approx. 9 mlIntended blood collection per tube
1200 × gStandard RCF for 7 minutes
Certification and regulatory status
Vi PRP-PRO is CE marked as a Class IIa medical device under Directive 93/42/EEC and is covered by EC certificate 0425-MED-004180-00. This regulatory classification also applies to the sales unit containing two tubes.
The existing classification is based on European Medical Devices Directive 93/42/EEC.
The PRP-PRO commercial variant was added to the certificate scope by an ICIM confirmation dated 22 November 2023.
The product is supplied under the applicable European transitional provisions.
For purchasing and quality management: Certificate and manufacturer documents can be requested before ordering. The current documents issued by the manufacturer and notified body remain authoritative.
Request documentsWhen is the Vi PRP-PRO 2-pack useful?
The 2-pack contains the same Vi PRP-PRO tubes as the larger sales unit, but in a smaller pack size. It is suitable for professional users who initially require only a small quantity or who want to keep their stock deliberately limited.
Suitable for professionals who
- need two sterile PRP tubes rather than a larger sales unit,
- work with sodium citrate and a physical gel barrier,
- use a glass tube designed for approximately 9 ml of blood,
- apply the standard protocol of 1200 × g for 7 minutes,
- check compatibility with centrifuge, rotor and adapter before use.
Clear distinction
- Vi PRP-PRO is not a conventional PRF tube without anticoagulant.
- It is not a standard diagnostic tube for laboratory testing.
- Vi PRP-PRO does not contain melatonin.
- The smaller pack size does not change the intended purpose or instructions for use.
- Tubes with and without separation gel should not be exchanged without verification.
Technical data for the Vi PRP-PRO 2-pack
Key product information for purchasing, documentation and comparison with the existing clinical or laboratory workflow.
- Product name
- Vi PRP-PRO PRP tubes with anticoagulant and separation gel, 2-pack
- Article number
- 1001001
- Manufacturer
- D-BIOTECH S.R.L.S., Catania, Italy
- Pack contents
- 2 sterile PRP tubes
- Vacuum / blood collection
- Designed for approximately 9 ml of blood per tube
- Material
- Borosilicate glass, wall thickness 2.4 mm
- Anticoagulant
- 0.8 ml sodium citrate per tube
- Separation component
- Biocompatible thixotropic separation gel
- Melatonin
- Not included
- Possible PRP yield
- Approximately 4–4.5 ml per tube; the actual volume depends on the starting material and preparation process
- Standard centrifugation
- 1200 × g for 7 minutes
- CE marking
- CE 0425
- Risk class
- Class IIa under Directive 93/42/EEC
- EC certificate
- 0425-MED-004180-00
- Intended users
- Qualified healthcare professionals and professional purchasers
- EAN
- 4170000035633
Important when selecting the product: The 2-pack is not a technically different version. It contains Vi PRP-PRO tubes with the same product-specific characteristics as the larger sales unit. The intended purpose, instructions for use and compatibility with the centrifuge system remain decisive.
1200 × gfor 7 minutes
Standard centrifugation based on RCF
For Vi PRP-PRO, the technical standard is a relative centrifugal force of 1200 × g for 7 minutes. The required rotational speed in rpm depends on the maximum rotor radius of the centrifuge used.
An rpm value must therefore not be transferred from one centrifuge model to another without verification. The calculation requires the distance from the axis of rotation to the bottom of the inserted tube in its operating position.
Orientation values for selected centrifuges
The target value for Vi PRP-PRO is 1200 × g for 7 minutes. The speeds below are rounded orientation values for selected devices.
Hettich EBA 200 / EBA 200 MD
ca. 3500 rpmOrientation value for 1200 × g
Hettich EBA 270
ca. 2900 rpmOrientation value for 1200 × g
SERVOspin Evolve
ca. 3400 rpmOrientation value for 1200 × g
Note: The actual rotor radius, rotor, adapter, tube position and the instructions for use of both tube and centrifuge remain decisive. If the configuration differs, the required speed must be recalculated.
Vi PRP-PRO in the professional preparation workflow
The following overview is intended for technical orientation. The current instructions for use, approval of the centrifuge used and the operating procedures of the responsible medical facility remain binding.
1. Blood collection
The vacuum is designed for approximately 9 ml of blood per tube. Sodium citrate and separation gel are already contained in the tube.
2. Centrifugation
The standard value is 1200 × g for 7 minutes. Tubes, rotor and adapters must be inserted symmetrically and balanced according to the device instructions.
3. Fraction separation
During centrifugation, the thixotropic gel supports physical separation of the blood fractions. Further collection is performed according to the procedure specified for the system.
4. Documentation
Depending on the internal quality-management system, the centrifuge model, rotor, adapter, RCF, run time, batch and accessories used may be documented.
Regular demand? Vi PRP-PRO is also available as a 10-pack
The larger sales unit contains ten sterile Vi PRP-PRO tubes and is intended for practices with regular consumption. Product specifications and the standard protocol are identical.
Classifying and comparing PRP tubes
Pack size and price should not be the only selection criteria. Material, additives, intended blood volume, centrifugation protocol and compatibility with the existing system are also relevant.
International availability through prpmed.de
prpmed.de ships Vi PRP-PRO PRP tubes to professional customers in numerous European and international markets. Actual availability depends on the destination country, the available shipping route and the applicable import and product regulations.
Available destinations and shipping costs are shown during checkout. For larger quantities or regular orders, the 10-pack is usually the more suitable pack size.
Frequently asked questions about the Vi PRP-PRO 2-pack
What does the Vi PRP-PRO 2-pack contain?
The sales unit contains two sterile Vi PRP-PRO vacuum tubes made of borosilicate glass. Each tube contains 0.8 ml sodium citrate and a thixotropic separation gel.
Are the tubes identical to those in the 10-pack?
Yes. They are the same Vi PRP-PRO tube system. The only difference is the pack size: two tubes instead of ten.
How much PRP can be obtained from one tube?
Approximately 4–4.5 ml per tube can be used as an orientation value. The actual volume depends on the starting material and preparation process.
Which centrifugation protocol applies?
The standard value is 1200 × g for 7 minutes. The required speed in rpm is calculated from the rotor radius of the centrifuge used.
Why do rpm values differ between centrifuges?
Relative centrifugal force depends on both speed and rotor radius. The same target of 1200 × g may therefore require different rpm settings on different centrifuges.
Does Vi PRP-PRO contain melatonin?
No. Vi PRP-PRO contains sodium citrate and a thixotropic separation gel, but no melatonin.
Is Vi PRP-PRO a PRF tube?
No. Vi PRP-PRO is a PRP tube with sodium citrate and separation gel. Conventional PRF tubes are often used without anticoagulant and are therefore not equivalent.
Which CE marking does the product carry?
Vi PRP-PRO carries CE marking CE 0425 and is classified as a Class IIa medical device under Directive 93/42/EEC.
Who is the 2-pack intended for?
The product is intended for qualified healthcare professionals and professional purchasers in practices, clinics and medical facilities. Use and preparation must follow the instructions for use and internal procedures.
Professional and regulatory note: The information on this page describes technical product characteristics and does not replace the current instructions for use, conformity documents or certificates. Before use, verify the intended purpose, manufacturer documentation, centrifuge approval, rotor and adapter compatibility and internal operating procedures.
- Features
4170000035633
PRP TECHNOLOGY FOR PROFESSIONAL USERS
PRPmed.de – Specialist shop for PRP technology
Carefully selected products for the professional collection, preparation and application of platelet-rich plasma.
Focused specialist range
Practical product data
Shipping to many countries
PRPmed.de
What is PRP?
PRP stands for platelet-rich plasma. Centrifugation is used to obtain a plasma fraction with an increased platelet concentration from a blood sample. PRP is used and scientifically investigated in a range of medical and aesthetic fields. A qualified practitioner assesses whether an application is appropriate based on the indication and the procedure used.
PRPmed.de
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When selecting products, we look for transparent technical data, a clearly defined intended purpose and sensible component compatibility. Many product pages include information on materials, fill volume, additives, centrifugation and regulatory status. A single product cannot guarantee a medical outcome.
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Our customer service team assists with questions about products, availability and suitable accessories. Medical or therapeutic decisions remain the responsibility of appropriately qualified professionals.
Find the right materials for your workflow
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GPSR – General Product Safety Regulation
Responsible Economic Operator according to GPSR:
prpmed Funkner e.K.
Siemensstraße 32
35440 Linden
Germany
Phone: +49 6043 9862 817
Email: [email protected]
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