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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

1008-00 — IVDR Class A IVDR by Hettich AG

MD Atlas
Hettich AG

EUDAMED last updated this device on Apr 26, 2024

1008-00

07640173551008-0029

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Hettich AG
UDI-DI code: 07640173551003
Reference / catalog number: 1008-00

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Manufacturer information

Organization name: Hettich AG
SRN: CH-MF-000041657
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: 07640173551003
Basic UDI-DI: 07640173551008-0029
Reference / catalog number: 1008-00
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: An automated mains electricity (AC-powered) laboratory instrument intended to be used to separate red blood cells from whole blood and wash the intact red blood cells, typically through low-speed centrifugal force, to remove plasma, debris and/or any other extraneous material so they are free from interfering substances and suitable for use in subsequent in vitro clinical testing (e.g., antiglobulin). The device operates with minimal technician involvement and complete automation of all procedural steps.
Additional information URL: https://www.hettich.ch/
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

Related devices

1008-00S07640173551008-00S49On 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.