R-EXB/T

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

  EUDAMED did not publish a description for this code.
• CW001

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.
• CW999

  CONTRA-INDICATIONS Absolute contraindications: • Platelet dysfunction syndrome • Critical thrombocytopenia • Hemodynamic instability • Severe metabolic or systemic disorders • Septicemia • Acute/local infection at the site of the procedure • Patient unwilling to accept risks • Hypersensitivity to one of the components Relative contraindications: • Consistent use of NSAIDs within 48 hours before the procedure • Consistent use of other medication(s) or dietary supplement(s) which alter platelet function, within 3 days before the procedure • Corticosteroid injection at the treatment site within 1 month before the procedure • Systemic use of corticosteroids within 2 weeks before the procedure • Tobacco use • Recent fever or illness • Malignant diseases, especially those aff ecting blood, bone marrow or bones, and cancers in metastatic phase • Autoimmune diseases with presence of antibodies and progressive (Hashimoto, rheumatoid arthritis, lupus, etc.) • Impaired coagulation • Hemoglobin count < 10 g/dl • Platelet count < 10^5/ μl

Primary placement in France; available across 32 countries total.

Trade name

not provided

UDI-DI code

07640138980121

Basic UDI-DI

764013898RKEXTRACELLBMCM6

Reference / catalog number

R-EXB/T

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Sterilized using irradiation

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• B019001PLATELET GEL AND FIBRIN GLUE PRODUCTION BAGS AND KITS

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification