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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

12014332 — IVDR Class A IVDR by Bio-Rad Medical…

MD Atlas
Bio-Rad Medical Diagnostics GmbH

EUDAMED last updated this device on Dec 19, 2022

12014332

361052A002928C

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Bio-Rad Medical Diagnostics GmbH
UDI-DI code: 03610522203338
Reference / catalog number: 12014332

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Manufacturer information

Organization name: Bio-Rad Medical Diagnostics GmbH
SRN: DE-MF-000019864
Manufacturer status: Active

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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.

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: not provided
UDI-DI code: 03610522203338
Basic UDI-DI: 361052A002928C
Reference / catalog number: 12014332
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: MLB 2 is a low ionic strength solution intended to be used as an enhancement for human red blood cell antibody/antigen reactions in the tube method as part of immunohematology testing. For in vitro diagnostic use, by trained laboratory personnel.
Additional information URL: https://downloads.bio-rad.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0103030306ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Software identification