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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

SOLEA 100 - FULL AUTOMATED… — IVDR Class A IVDR by BIOLABO

MD Atlas
BIOLABO

EUDAMED last updated this device on Aug 30, 2023

SOLEA 100 - FULL AUTOMATED COAGULATION ANALYSER, including accessories

376017308S1005N

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: BIOLABO
UDI-DI code: 03760173087228
Reference / catalog number: SOLEA 100

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Manufacturer information

Organization name: BIOLABO
SRN: FR-MF-000001633
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: SOLEA 100 - FULL AUTOMATED COAGULATION ANALYSER, including accessories
UDI-DI code: 03760173087228
Basic UDI-DI: 376017308S1005N
Reference / catalog number: SOLEA 100
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Enclosed accessories: 050-618OD: Reagent containers 16mm / 100 pcs For storage of reagent on board RC610: Reagent containers 25mm - SOLEA / 100 pcs For storage of reagent on board LRC710: Lids for reagent containers 25mm / 25 pcs To close reagent container RC611: Reagent containers 30mm - SOLEA / 100 pcs For storage of reagent on board LRC711: Lids for reagent containers 30mm / 25 pcs To close reagent container 054-522OD: Racks of predilution cuvettes For storage of cups on board to perform automatic pre-dilution MS8MM: Magnetic bars (8x1,5mm) / 10 pcs To mix reagents (suspension)
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0202020102AUTOMATED COAGULOMETERS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.