Organization name

Regen Lab SA

SRN

CH-MF-000032231

Manufacturer status

Active

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

• Consult instructions for use
• Do not re-use
• Do not resterilize
• Do not use if package is damaged
• Do not use past indicated date
• 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

  OTHER

Primary placement in France; available across 32 countries total.

Trade name

RegenKit® Extracell BMC

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

07640138980121

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

764013898RKEXTRACELLBMCM6

Reference / catalog number

R-EXB/T

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

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.

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

European Medical Device Nomenclature — the EU product classification assigned to this device.

• B019001PLATELET GEL AND FIBRIN GLUE PRODUCTION BAGS AND KITS

• Class IIb medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.

Certificate health across this manufacturer's portfolio.