A-CP-HA-3

Organization name

Regen Lab SA

SRN

CH-MF-000032231

Manufacturer status

Active

6 warnings recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.
• CW009

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• CW001

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• CW007

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• CW032

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• CW999

  CONTRA-INDICATIONS Absolute contraindications: Do not administer the PRP /HA preparation to patients with ascertained hypersensitivity to one of the components, including hyaluronic acid. Do not use on patients with hereditary or acquired hematologic /coagulation disorders such as platelet dysfunction syndrome, critical thrombocytopenia, impaired coagulation or patients suffering from uncontrolled severe metabolic or systemic disorders. Do not treat patients who present septicemia or acute infection in the area of the treatment. It is recommended not to use the PRP /HA preparation in patients with partial or total knee prosthesis. Relative contraindications: It is recommended not to use the PRP /HA preparation in patients with malignancy, particularly with hematologic or bone involvement and metastatic disease, in the previous 5 years, with autoimmune diseases with presence of antibodies and progressive (Hashimoto, rheumatoid arthritis, lupus, etc ), with recent fever or illness and with platelet count less than 100’000’000 /ml. Taking medication or dietary supplement which alter platelet function, within 3 days, may affect the effectiveness of the treatment. The safety and effectiveness have not been evaluated in children and in pregnant or lactating women. It is recommended not to use the PRP /HA preparation in patients with local dermatological diseases at the site of injection.

Primary placement in France; available across 32 countries total.

Trade name

not provided

UDI-DI code

07640138980343

Basic UDI-DI

B-07640138980343

Reference / catalog number

A-CP-HA-3

Issuing entity

GS1

Risk category

Class III

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Sterilized using steam

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES

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