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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-ROMANOWSKI solution — IVDR Class A IVDR

MD Atlas
Ing. Petr Švec - PENTA s.r.o.

EUDAMED last updated this device on Aug 14, 2024

GIEMSA-ROMANOWSKI solution

85951422144607R

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Ing. Petr Švec - PENTA s.r.o.
UDI-DI code: 08595142233215
Reference / catalog number: 14460-11000

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Manufacturer information

Organization name: Ing. Petr Švec - PENTA s.r.o.
SRN: CZ-MF-000035988
Manufacturer status: Active

Critical warnings

5 warnings recorded — scroll inside the panel to see all entries.

CW057
EUDAMED did not publish a description for this code.
CW075
EUDAMED did not publish a description for this code.
CW079
EUDAMED did not publish a description for this code.
CW087
EUDAMED did not publish a description for this code.
CW099
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Czechia; available across 2 countries total.

Country	On market since	Until
CzechiaPrimary placement		Still on market
Slovakia		Still on market

Device identification

Trade name: GIEMSA-ROMANOWSKI solution
UDI-DI code: 08595142233215
Basic UDI-DI: 85951422144607R
Reference / catalog number: 14460-11000
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)

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.