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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

5428 000.619 — IVDR Class A IVDR by Eppendorf SE

MD Atlas
Eppendorf SE

EUDAMED last updated this device on Jul 24, 2024

5428 000.619

04043758-IA-CEN-007-PA

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Eppendorf SE
UDI-DI code: 04043758016547
Reference / catalog number: 5428 000.619

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Manufacturer information

Organization name: Eppendorf SE
SRN: DE-MF-000006237
Manufacturer status: Active

Related devices

5401 000.01304043758-IA-CEN-011-NVOn the market 5420 000.01604043758-IA-CEN-008-PDOn the market 5420 000.21004043758-IA-CEN-008-PDOn the market 5405 000.15804043758-IA-CEN-009-PGOn the market 5405 000.41704043758-IA-CEN-009-PGOn the market

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: 04043758016547
Basic UDI-DI: 04043758-IA-CEN-007-PA
Reference / catalog number: 5428 000.619
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W02069003CENTRIFUGES

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

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.