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Technical information for medical professionals and procurement
Vi PRP-PRO PRP tubes: technical data and regulatory status
Vi PRP-PRO is a sterile borosilicate-glass vacuum tube for the professional preparation of autologous platelet-rich plasma (PRP). The tube contains 0.8 ml sodium citrate as anticoagulant and a thixotropic separation gel. This facts article explains the product design, CE 0425, the MDD Class IIa status, the MDR transition and the standard protocol of 1200 × g for 7 minutes.
CE 0425CE marking involving the notified body ICIM
Class IIaexisting classification under Directive 93/42/EEC
approx. 9 mlintended blood draw by vacuum
1200 × gstandard RCF with a runtime of 7 minutes
10 tubessterile tubes per sales unit
What is Vi PRP-PRO?
Vi PRP-PRO is a vacuum tube for a professional PRP preparation workflow using an anticoagulant and a physical gel barrier. Selection and use must follow the intended purpose, instructions for use, available centrifuge and the internal workflow.
Design of the PRP tube
- borosilicate glass with a stated wall thickness of 2.4 mm
- vacuum intended to collect approximately 9 ml of blood
- 0.8 ml sodium citrate as anticoagulant
- thixotropic separation gel as the physical separating component
- sterile single-use product supplied in a sales unit of 10 tubes
Clear distinction
- Vi PRP-PRO is not an anticoagulant-free PRF tube.
- Vi PRP-PRO does not contain melatonin.
- Similar dimensions do not mean that tube systems are interchangeable.
- The intended purpose, manufacturer documentation and approved process remain decisive.
After centrifugation, the separation gel forms a barrier between the separated components. The product information gives approximately 4 to 4.5 ml PRP per tube as an orientation value. The actual volume may be affected by the starting material, correct filling, rotor geometry, RCF, runtime and handling and is not guaranteed in every individual case.
Technical data for Vi PRP-PRO PRP tubes
This overview is intended for procurement and comparison with existing clinical or laboratory workflows. Before use, the labelling, instructions for use and documentation for the respective batch are decisive.
- Product name
- Vi PRP-PRO PRP tubes with sodium citrate and separation gel
- Article number
- 100101
- Manufacturer
- D-BIOTECH S.R.L.S., Corso Italia 298, 95129 Catania, Italy
- Package contents
- 10 sterile tubes
- Vacuum / blood draw
- designed for approximately 9 ml blood collection per tube
- Material
- borosilicate glass, stated wall thickness 2.4 mm
- Anticoagulant
- 0.8 ml sodium citrate
- Separation component
- thixotropic separation gel
- Melatonin
- not included
- PRP volume orientation value
- approximately 4 to 4.5 ml per tube; dependent on starting material and preparation
- Standard centrifugation
- 1200 × g for 7 minutes
- CE marking
- CE 0425
- Existing risk class
- Class IIa under Directive 93/42/EEC
- Certificate reference
- EC Certificate 0425-MED-004180-00, with the PRP-PRO trade variant added on 22 November 2023
- MDR transition
- formal MDR application and written agreement with PCBC, identification number 1434, confirmed
- Intended users
- appropriately trained medical or nursing professionals acting under medical responsibility
CE 0425, MDD Class IIa and MDR transition
The regulatory information must be considered separately. The existing CE marking and Class IIa classification are based on Directive 93/42/EEC. In a letter dated 22 November 2023, ICIM documented PRP-PRO as an additional trade variant within the certificate context 0425-MED-004180-00.
CE markingCE 0425
Identification number 0425 belongs to ICIM S.p.A., the notified body that issued the underlying MDD certificate.
Existing classificationClass IIa medical device
The Class IIa classification shown here refers to Directive 93/42/EEC.
Certificate reference0425-MED-004180-00
PRP-PRO was documented as an additional trade variant in an ICIM letter dated 22 November 2023.
MDR transitionProcedure initiated
A formal MDR application and the written agreement with PCBC, identification number 1434, have been confirmed.
Transparent status statement: The confirmation letter from the notified body PCBC dated 24 July 2024 states a transitional period up to 31 December 2028 for the covered product. This period applies only while the conditions of Article 120(3c) MDR continue to be met. These include continued MDD compliance, no significant change in design or intended purpose, no unacceptable risk and the timely formal application and written agreement with a notified body. This statement is not evidence of a completed MDR conformity assessment and is not an MDR certificate.
What CE 0425 does not prove: CE marking is not a comparative quality seal. It does not prove therapeutic superiority or guarantee a successful treatment outcome compared with other tube systems. Medical efficacy or success claims cannot be derived from CE marking.
Standard protocol: 1200 × g for 7 minutes
1200 × gfor 7 minutes
RCF is the transferable value
RCF describes the relative centrifugal force. The RPM required to achieve it depends on the effective rotor radius of the centrifuge used. A single RPM value therefore cannot be transferred correctly to every device.
The table provides calculated orientation values for 1200 × g. It is based on the formula RCF = 1.118 × 10−5 × r × RPM², with the effective radius r entered in centimetres.
Note: On small screens, the table can be scrolled horizontally.
| Effective rotor radius | Approximate speed for 1200 × g | Classification |
|---|---|---|
| 50 mm | approx. 4630 RPM | a smaller radius requires a higher speed |
| 75 mm | approx. 3780 RPM | medium rotor radius |
| 86 mm | approx. 3530 RPM | orientation value for devices with an effective radius of about 86 mm |
| 100 mm | approx. 3280 RPM | a larger radius requires a lower speed |
Not a device-specific approval: These values are a calculation aid. The actual effective radius, rotor type, tube position, permitted load and the manufacturer information for the tube and centrifuge remain decisive.
International ordering and delivery check
Professional customers can order Vi PRP-PRO through prpmed.de for delivery to numerous European and selected other countries. A specific delivery commitment depends on the destination country, import rules, regulatory requirements and the available shipping route.
For this reason, the product is not advertised with an unrestricted claim of “worldwide delivery”. Some countries may be excluded or require additional documentation or specific import procedures. Deliveries outside the European Union may also incur customs duties, import VAT and other recipient charges.
For larger orders or deliveries to third countries, professional purchasers should provide the destination country, quantity and intended use in advance. prpmed.de can then check current delivery options and available product documentation.
Document basis for this facts article
The regulatory statements are based on the available manufacturer and notified-body documents. For procurement and quality management, current original documents should be requested when required and compared with the delivered batch.
Manufacturer's instructions for useD-BIOTECH S.R.L.S.; product description and intended professional user group.
ICIM letter dated 22 November 2023Reference BO/2023/0899/LG-sm; addition of the PRP-PRO trade variant to certificate reference 0425-MED-004180-00.
PCBC confirmation dated 24 July 2024Reference BM.433.0167.2024/KW/MC/2024/0341; formal MDR application, written agreement and transitional status.
Legal framework: Article 120 MDRThe legal conditions for the transitional provisions are set out in the consolidated Regulation (EU) 2017/745.
Further information for professional users
These pages provide more detail on product selection, regulatory assessment and centrifugation without duplicating the Vi PRP-PRO product page.
PRP tubes overviewTube systems with and without separation gel and their distinction from PRF products.
CE, MDR and intended purposeMarkings and documents relevant to professional product selection.
RCF/RPM calculatorConvert RCF and RPM correctly using the effective rotor radius.
Centrifuges for PRP and PRFCompare devices by RCF, rotor, tube format and regulatory status.
Frequently asked questions about Vi PRP-PRO
What does a Vi PRP-PRO tube contain?
The borosilicate-glass tube contains 0.8 ml sodium citrate as anticoagulant and a thixotropic separation gel. It does not contain melatonin.
How much blood is intended for one tube?
The vacuum is designed for approximately 9 ml of blood. The labelling and instructions for use of the batch actually used remain decisive.
What is the standard centrifugation protocol?
The stated standard value is 1200 × g for 7 minutes. The corresponding RPM depends on the effective rotor radius of the centrifuge.
Is Vi PRP-PRO already MDR-certified?
No completed MDR certification is claimed. Vi PRP-PRO is presented as a CE-marked legacy device with an existing Class IIa classification under Directive 93/42/EEC. The formal MDR application and a written agreement with the notified body have been confirmed.
What does the transitional period to 31 December 2028 mean?
The PCBC confirmation letter states this date for the documented transitional status. Continued validity requires the legal conditions of the MDR transitional provisions to remain fulfilled. The date is not an MDR certificate.
Can Vi PRP-PRO be used with every centrifuge?
No. Tube format, rotor holder, permitted load, effective rotor radius, achievable RCF and the manufacturer information for the centrifuge must be checked.
Can Vi PRP-PRO be ordered internationally?
Delivery can be checked for numerous European and selected other countries. Actual availability depends on import rules, regulatory requirements and the available shipping route.
Who is Vi PRP-PRO intended for?
Use is reserved for appropriately trained medical or nursing professionals acting under medical responsibility. The product is not intended for independent use by consumers.
