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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

1008-00S — IVDR Class A IVDR by Hettich AG

MD Atlas
Hettich AG

EUDAMED last updated this device on Apr 26, 2024

1008-00S

07640173551008-00S49

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: 07640173554004
Reference / catalog number: 1008-00S

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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: 07640173554004
Basic UDI-DI: 07640173551008-00S49
Reference / catalog number: 1008-00S
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 electrically-powered device intended to be used in a clinical laboratory setting to separate the cellular components of suspensions in a clinical specimen through centrifugal force for subsequent cytological analysis. It is typically a compact unit with an electric motor, a vertical shaft, and a special horizontal rotor attached that enables cells to be separated from a liquid suspension and deposited directly onto a microscope slide for microscopic examination.
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

1008-0007640173551008-0029On 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.