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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

806505 — IVDR Class A IVDR by Bio-Rad Medical…

MD Atlas
Bio-Rad Medical Diagnostics GmbH

EUDAMED last updated this device on Dec 19, 2022

806505

361052A002918A

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: 07611969951338
Reference / catalog number: 806505

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Manufacturer information

Organization name: Bio-Rad Medical Diagnostics GmbH
SRN: DE-MF-000019864
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: not provided
UDI-DI code: 07611969951338
Basic UDI-DI: 361052A002918A
Reference / catalog number: 806505
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: Alsevers F is a human red blood cell preservative solution that permits the storage of red blood cells for further use in immunohematology tests. 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)

W010399HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYSTOLOGY REAGENTS - OTHER

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

806506361052A002918AOn the market 12014332361052A002928COn the market 805200361052A002928COn the market 805205361052A002928COn the market 805060361052A002938EOn the market

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.