Question 1

What types of medical devices does Laboratoire Verbièse manufacture?

Accepted Answer

Laboratoire Verbièse specializes in producing chemical solvents and reagent mixtures. These include fixed-mix solutions like the *Fixateur par mélange* and various solvent and reagent blends tailored for laboratory use. The devices are designed for precision applications in research, diagnostics, and analytical procedures, ensuring compatibility with specific testing requirements.

Question 2

Where is Laboratoire Verbièse based, and how does this affect its regulatory compliance?

Accepted Answer

Laboratoire Verbièse is based in France, which places its operations under EU regulatory oversight. Since all its devices fall under Class A classification, they must comply with EU Medical Device Regulations (MDR) or the Medical Device Directive (MDD), depending on the applicable timeline. The company’s location ensures alignment with EU standards for chemical-based medical solutions, including traceability and safety requirements.

Question 3

Are Laboratoire Verbièse’s devices listed in any regulatory registries, and why?

Accepted Answer

Yes, all of Laboratoire Verbièse’s devices are listed in the EU’s *eudamed* registry. This is mandatory for Class A devices under EU regulations, as eudamed serves as the central database for tracking medical devices within the European Economic Area. Listing ensures transparency, traceability, and compliance with EU market surveillance requirements.

Question 4

How are Laboratoire Verbièse’s devices classified, and what does this classification mean?

Accepted Answer

Laboratoire Verbièse’s devices are classified as *Class A* under EU regulations. This classification applies to low-risk medical devices, such as certain chemical solvents and reagent mixtures, which pose minimal risk to patients or users. Class A devices typically require less stringent clinical evaluation but still must meet essential safety and performance requirements, including proper labeling and manufacturing controls.

Catalogue53

Reagent Ref 512313_34

Reagent Ref 512313_33

Solvent Ref 01932_33

Reagent Ref 513325_32

Fixateur par mélange Ref 264432_41

Solvent Ref 01932_35

Reagent Ref 513325_33

Solvent Ref 01912_35

Solvent Ref 01903_35

Reagent Ref 513325_34

Solvent Ref 01903_33

Reagent Ref 513325_31

Reagent Ref 512313_31

Solvent Ref 512824_35

Solvent Ref 512983_35

Solvent Ref 512824_33

Solvent Ref 01256_33

Solvent Ref 01912_33

Reagent Ref 512313_32

Solvent Ref 01922_35

Solvent Ref 01256_35

Solvent Ref 512983_33

Solvent Ref 01922_33

Verbiese Ref 512029_35

Formol tamponné pbs 4 % tube 6 ml - 5 ml Ref 512029_24

Formol tamponné pbs 4 % - 35 ml / 60 ml Ref 512029_65

Formol tamponné pbs 4 % dans flacon 3000 ml Ref 512029CON3000

Formol tamponné pbs 4 % - 250 ml / 500 ml Ref 512029_31

Formol tamponné pbs 4 % - 25 ml / 60 ml Ref 512029_28

Verbiese Ref 512029_48

Formol tamponné pbs 4 % en solution Ref 512029SOL

Fixateur de Duboscq-Brasil dans 60 ml - 20 ml Ref 512936_23

Verbiese Ref 512302_37

Formol tamponné pbs 4 % - 30 ml / 60 ml Ref 512029_50

Formol tamponné pbs 4 % - 10 ml / 20 ml Ref 512029_27

Verbiese Ref 512029_69

Formol tamponné pbs 4 % - 60 ml / 125 ml Ref 512029_76

Formol tamponné pbs 4 % - 150 ml / 250 ml Ref 512029_82

Formol tamponné pbs 4 % - 20 ml / 60 ml Ref 512029_23

Formol tamponné pbs 4 % - 120 ml / 180 ml Ref 512029_71

Formol tamponné pbs 4 % - 40 ml / 60 ml Ref 512029_39

Verbiese Ref 512029_36

Formol tamponné pbs 4 % - 80 ml / 180 ml Ref 512029_51

Formol tamponné pbs 4 % - 100 ml / 180 ml Ref 512029_30

Formol tamponné pbs 4 % - 148 ml / 180 ml Ref 512029_80

Verbiese Ref 512029_37

Formol tamponné pbs 4 % rosé dans flacon 60 ml Ref 512685CON60

Formol tamponné pbs 4 % - 75 ml / 180 ml Ref 512029_90

Formol tamponné pbs 4 % - 500 ml / 1000 ml Ref 512029_32

Formol tamponné pbs 4 % - 65 ml / 180 ml Ref 512029_78

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