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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

Giemsa — IVDR Class A IVDR by Cypress Diagnostics

MD Atlas
Cypress Diagnostics

EUDAMED last updated this device on Nov 17, 2023

Giemsa

54040351HS00365

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: 05404035100127
Reference / catalog number: HS003

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Manufacturer information

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

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: Giemsa
UDI-DI code: 05404035100127
Basic UDI-DI: 54040351HS00365
Reference / catalog number: HS003
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 Giemsa and May-Grünwald stains are in vitro diagnostic medical devices intended to be used to be used in hematology and histology for the differential staining of nuclei and cytoplasm of different cell types, mainly blood cells. The staining is performed on air dried smears of blood and bone marrow, smears of body fluids or tissue. The devices are 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)

W0103010302ROMANOWSKY STAINS

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

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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.