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Reference / catalog number

SputofluolTM for microscopy — IVDR Class A IVDR by Merck KGaA

MD Atlas
Merck KGaA

EUDAMED last updated this device on Apr 17, 2026

SputofluolTM for microscopy

4027269108000UC

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Merck KGaA
UDI-DI code: 04027269571689
Reference / catalog number: 1080009030

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Manufacturer information

Organization name: Merck KGaA
SRN: DE-MF-000018777
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
Consult instructions for use

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: SputofluolTM for microscopy
UDI-DI code: 04027269571689
Basic UDI-DI: 4027269108000UC
Reference / catalog number: 1080009030
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: This “SputofluolTM - for microscopy” is used for human-medical cell diagno - sis and serves the purpose of the microbiological investigation of sample material of human origin. It is a ready-to-use solution for the pretreatment of specimen material that when used together with other in vitro diagnostic products from our portfolio makes bacterial and mycotic target structures evaluable for diagnostic purposes (e. g. acid-fast bacteria (AFB)) by fixing, staining, counterstaining, mounting in microbiological specimen materials, for example smears of enriched bacterial cultures of e. g. the lung.
Additional information URL: https://www.sigmaaldrich.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0104010804STAINS

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Safety

Sterile

Single use

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New device

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