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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

Ziehl-Neelsen — IVDR Class A IVDR by Cypress Diagnostics

MD Atlas
Cypress Diagnostics

EUDAMED last updated this device on Nov 17, 2023

Ziehl-Neelsen

54040351HS00263

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Cypress Diagnostics
UDI-DI code: 05404035100233
Reference / catalog number: HS002

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Manufacturer information

Organization name: Cypress Diagnostics
SRN: BE-MF-000000033
Manufacturer status: Active

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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.

Critical warnings

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

CW010
See IFU

Market distribution

Primary placement in Belgium; available across 1 country total.

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

Device identification

Trade name: Ziehl-Neelsen
UDI-DI code: 05404035100233
Basic UDI-DI: 54040351HS00263
Reference / catalog number: HS002
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: The Cypress Diagnostics Ziehl-Neelsen stains are in vitro diagnostic medical devices intended to be used for the differentiation of acid-fast bacteria (such as Mycobacteria and Nocardia species and the cysts of Cryptosporidium and Isospora) from non-acid-fast bacteria. The staining is performed on smears from various body fluids. The device is not automated. It is a qualitative staining that provides information on the physiological or pathological state of the tissue sample when the staining obtained is interpreted by a trained professional. To obtain a diagnosis, the result is utilized alongside other information such as the patient’s medical history, physical status as well as other clinical and laboratory data obtained. This kit is intended to be used by healthcare professionals in a laboratory-based testing environment.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0104010804STAINS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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