In-vitro diagnostics · Kaarst, Germany
Blood diagnostics, connected.
Cyclora Health links manufacturers of diagnostic tests with laboratories in Germany and Europe. Our work is grounded in haemostasis, the science of blood coagulation.
Haemostasis
We know what happens in the sample.
When blood clots, fibrinogen turns into a mesh of fibrin within seconds. Measuring that moment reliably is the basis of PT, APTT and fibrinogen testing, and it is where our expertise comes from.
Technical partner
Backed by a specialist manufacturer.
Heamostica develops and produces coagulation reagents under an ISO 13485 quality management system. Its scientists support us in product evaluation, application questions and training.
For manufacturers
Your products, in expert hands.
We assess your portfolio technically, purchase in dependable volumes and build long-term representation in Germany and Europe.
Cyclora Health
Full circle, from manufacturer to laboratory.
Talk to us about purchasing, distribution or technical cooperation.
Focus areas
Blood diagnostics is our field.
We concentrate on product groups we understand in depth, from the reagent to the instrument it runs on.
Routine coagulation
Global tests of the extrinsic, intrinsic and common pathway, for manual through fully automated systems. Our technical partner manufactures PT, APTT and Clauss fibrinogen reagents.
Special haemostasis
Thrombophilia and lupus anticoagulant testing, natural inhibitors and chromogenic assays.
Quality control
Control plasmas and calibrators for daily run release and external quality assessment.
Analysers and consumables
Coagulometers, cuvettes, test beads and system solutions. We know the instruments reagents have to perform on.
Immunohaematology
Blood grouping and compatibility testing, a founding field of our technical partner.
Rapid diagnostics
Immunochromatographic tests that deliver answers within minutes, including outside the central laboratory. Tests for faecal occult blood and drug screening are part of our technical partner’s range.
Know-how
Reading a clot curve.
Optical coagulometers measure how the absorbance of a plasma sample rises as fibrin forms. The clotting time is read at the steepest point of the curve. Understanding these signals lets us judge whether a reagent and an analyser work well together.
- Sample
- Citrated plasma, 3.2% sodium citrate
- Method
- Photo-optical clot detection at 37 °C
- Result
- Clotting time in seconds and INR
Prothrombin time (PT) · 37 °C
Optical clot curve
Absorbance, normalised
Time (s)
- 1Lag phase 0–10 s
Thrombin is being generated, the sample is still liquid. - 2Fibrin polymerisation 10–16 s
Fibrin strands form and the absorbance rises steeply. - 3Plateau from 16 s
The clot is complete and the signal levels off.
Partnership
What manufacturers can expect from us.
We want to represent a small number of products well. That shapes how we evaluate, buy and support them.
Technical due diligence
Before we commit, our specialists review instructions for use, performance data and instrument compatibility. We only take on products we can support.
Dependable purchasing
Forecast-based orders and one point of contact for supply planning, logistics and documentation.
Regulatory diligence
We take on the obligations of importer and distributor under the EU IVDR: we check CE marking, labelling and instructions for use, keep products traceable and pass on complaints.
Market development
Application support, training and German-language documentation for users, and structured feedback from the field for your product team.
How a partnership starts
- 01
Introduction and NDA
A first call about your portfolio and goals, followed by a mutual confidentiality agreement.
- 02
Technical evaluation
We review the documentation and test samples together with our technical partner.
- 03
Commercial and regulatory framework
Prices, volumes, territory and the roles under the IVDR are agreed in writing.
- 04
Launch and support
First orders, market launch and ongoing support for users.
Technical partner
Heamostica: specialists in haemostasis.
Heamostica (Shafa Azmaye Parsian) is a knowledge-based company founded in 2017 by specialists in laboratory haematology and transfusion science. Research and production are based at the Stem Cell and Regenerative Medicine Innovation Center of Tehran University of Medical Sciences.
As our technical partner, the Heamostica team supports Cyclora Health with product evaluation, application know-how and training.
- Founded
- 2017
- Quality system
- ISO 13485, certified by IMQ
- Focus
- Haemostasis and immunohaematology
- Portfolio
- Routine and special coagulation, control plasmas, coagulometer consumables, rapid tests
Quality and compliance
Compliance from the first delivery.
Diagnostics reach patients only through a documented chain. We treat our part of that chain as seriously as the manufacturer treats theirs.
Regulation (EU) 2017/746
IVDR
Every product we place on the market must carry a valid CE marking under the IVDR. Before the first delivery we check the declaration of conformity, labelling, instructions for use and UDI.
IVDR Art. 13 and 14
Traceability
Lot-level records, a register of complaints and non-conforming products, and cooperation with manufacturers and authorities on corrective actions.
2–8 °C
Storage and transport
Conditions as specified by the manufacturer, for example 2–8 °C for reagents and control plasmas, documented from receipt to delivery.
Contact
Let’s talk about your products.
Whether you are looking for a purchasing partner or for representation in Germany and Europe, write to us. We are happy to sign an NDA before you share technical details.
Kirchstraße 18
41564 Kaarst
GermanyPhone+49 1522 4734312Emailinfo@cyclora-health.de