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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

Q Fix Michel's 2 (Fixative) — IVDR Class A IVDR

MD Atlas
biocyc Biotechnologie GmbH & Co. KG

EUDAMED last updated this device on Sep 14, 2023

Q Fix Michel's 2 (Fixative)

42555978FIXATIONDF

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: biocyc Biotechnologie GmbH & Co. KG
UDI-DI code: 04255597800496
Reference / catalog number: FX-003-0005

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Manufacturer information

Organization name: biocyc Biotechnologie GmbH & Co. KG
SRN: DE-MF-000031533
Manufacturer status: Active

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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: Q Fix Michel's 2 (Fixative)
UDI-DI code: 04255597800496
Basic UDI-DI: 42555978FIXATIONDF
Reference / catalog number: FX-003-0005
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)

W01030799HISTOLOGY / CYTOLOGY REAGENTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Manufacturing date
Serial number
Software identification

Certificates

Certificate health across this manufacturer's portfolio.

HX 1108389-1Issued
refdata.certificate-ivdr-type.quality-management-systemNotified body: 0197Expiry: Jun 20, 2029