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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

710-06 — IVDD — Annex II List A IVDD by Eldon Biologicals A/S

MD Atlas
Eldon Biologicals A/S

EUDAMED last updated this device on Nov 22, 2023

710-06

B-05713494002263

On the marketIVDD — Annex II List A

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Eldon Biologicals A/S
UDI-DI code: 05713494002263
Reference / catalog number: 710-06

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View device family (Basic UDI)

Manufacturer information

Organization name: Eldon Biologicals A/S
SRN: DK-MF-000025470
Manufacturer status: Active

Critical warnings

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

CW007
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Spain; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 05713494002263
Basic UDI-DI: B-05713494002263
Reference / catalog number: 710-06
Issuing entity: GS1

Classification

Risk category: IVDD — Annex II List A
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Para AB0 y Rh D agrupación de la sangre.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05713494002263

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EMDN nomenclature code(s)

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

W0103030999COMBINED ABO TYPING + RHESUS TYPING TEST - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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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.