Question 1

What types of medical devices does Diaco Biofarmaceutici srl manufacture?

Accepted Answer

Diaco Biofarmaceutici srl specializes in sterile liquid injectable products. Their portfolio includes local anesthetics like Diart 1 (available in varying concentrations and volumes) and hyaluronic acid-based dermal fillers such as Diart One and EasyGo One, which come in different strengths and packaging. They also produce sterile solutions like Instylan, designed for medical and aesthetic applications such as soft tissue augmentation.

Question 2

Where is Diaco Biofarmaceutici srl based?

Accepted Answer

Diaco Biofarmaceutici srl is based in Italy. The company’s headquarters and production facilities are located within the country, aligning with its focus on European regulatory compliance for its medical devices.

Question 3

Which regulatory registries list Diaco Biofarmaceutici srl’s devices?

Accepted Answer

Diaco Biofarmaceutici srl’s devices are registered in the eudamed database, which is the European Union’s central registry for medical devices. This platform ensures transparency and traceability of devices authorized under EU medical device regulations.

Question 4

How are Diaco Biofarmaceutici srl’s devices classified under EU regulations?

Accepted Answer

Diaco Biofarmaceutici srl’s devices fall into two classification categories under EU medical device regulations: Class III (for higher-risk products like certain injectable anesthetics) and Class IIa (for moderate-risk products such as hyaluronic acid-based dermal fillers). Classification depends on factors like intended use, duration of contact with the body, and potential risks.

Question 5

Why are some of Diaco’s devices classified as Class III?

Accepted Answer

Certain of Diaco Biofarmaceutici srl’s devices are classified as Class III because they pose higher risks to patients. For example, injectable anesthetics like Diart 1 can directly impact vital bodily functions (e.g., cardiovascular or respiratory systems) if misused or improperly administered. EU regulations mandate stricter scrutiny, manufacturing controls, and post-market surveillance for such high-risk devices to ensure patient safety.

Catalogue59

Diart One 40mg 2ml Ref 6509

Diart 1.8 % 1 ml Ref 6530

Diart 1.8 % 2 ml Ref 6532

Easygo 1.8% 2 ml Ref 6534

Diart One 60mg 2ml Ref 6542

Diart One 40mg 2ml Ref 6535

Diart One 90mg 3ml Ref 6547

Diart One 80mg 4ml Ref 6539

Diart One 60mg 2ml Ref 6545

Diart One 60mg 2ml Ref 6543

Perfoskin Device Ref 6068

Diart 1.8 % 2 ml Ref 6518

Diart One 60mg 2ml Ref 6544

Diart 1.1 % 1 ml Ref 6522

Diart 1.1 % 1 ml Ref 6521

Nasisoft Forte 3 Hyal Ref 6088

Diart One 80mg 4ml Ref 6538

Diart One 80mg 4ml Ref 6541

Nasisoft Ref 6060

Diart 1.8 % 2 ml Ref 6531

Diart 1.1 % 2 ml Ref 6526

Diart One 90 mg 3ml Ref 6546

Nasisoft Extra 7 Hyal Ref 6089

Diart One 40mg 2 ml Ref 6536

Diart One 90mg 3ml Ref 6505

Easygo One 90mg 3ml Ref 6549

Diart 1.8 % 2 ml Ref 6533

Diart One 80mg 4ml Ref 6540

Diart One 90mg 3ml Ref 6548

Diart One 40mg 2ml Ref 6537

Diart 1.1 % 1 ml Ref 6520

Diart 1.8 % 1 ml Ref 6529

Diart 1.1 % 2 ml Ref 6524

Diart 1.8 % 1 ml Ref 6528

Diart 1.8 % 1 ml Ref 6527

Diart 1.1 % 1 ml Ref 6519

Diart 1.1 % 2 ml Ref 6523

Diart 1.1 % 2 ml Ref 6525

Diart 1, 8% 1 ml Ref 6091

Diart 1, 1% 1 ml Ref 6095

Diart One 80 mg 4 ml Ref 6081

Instylan 0.16% Ref 6011

Diart One 90 mg 3 ml Ref 6113

EasyGo One 90 mg 3 ml Ref 6072

Diart One 60 mg 2 ml Ref 6111

Diart 1, 8% 1 ml Ref 6099

Diart One 40 mg 2 ml Ref 6104

Diart 1, 8% 2 ml Ref 6100

Diart 1, 1% 1 ml Ref 6053

Diart One 80 mg 4 ml Ref 6108

EUDAMED certificates3

ISTITUTO SUPERIORE DI SANITA' 0373 ·3 certificates

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ISTITUTO SUPERIORE DI SANITA' 0373 3 certificates