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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 Carnoy — IVDR Class A IVDR by biocyc Biotechnologie…

MD Atlas
biocyc Biotechnologie GmbH & Co. KG

EUDAMED last updated this device on Sep 18, 2023

Q Fix Carnoy

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: 04255597800533
Reference / catalog number: FX-004-0050

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Manufacturer information

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

Critical warnings

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

CW041
EUDAMED did not publish a description for this code.
CW043
EUDAMED did not publish a description for this code.
CW044
EUDAMED did not publish a description for this code.
CW057
EUDAMED did not publish a description for this code.
CW082
EUDAMED did not publish a description for this code.
CW085
EUDAMED did not publish a description for this code.
CW087
EUDAMED did not publish a description for this code.
CW093
EUDAMED did not publish a description for this code.
CW095
EUDAMED did not publish a description for this code.
CW097
EUDAMED did not publish a description for this code.
CW101
EUDAMED did not publish a description for this code.
CW105
EUDAMED did not publish a description for this code.
CW137
EUDAMED did not publish a description for this code.
CW139
EUDAMED did not publish a description for this code.
CW150
EUDAMED did not publish a description for this code.
CW158
EUDAMED did not publish a description for this code.
CW167
EUDAMED did not publish a description for this code.
CW313
EUDAMED did not publish a description for this code.
CW999
P403 + P233

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 Carnoy
UDI-DI code: 04255597800533
Basic UDI-DI: 42555978FIXATIONDF
Reference / catalog number: FX-004-0050
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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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On the market

Certificates

Certificate health across this manufacturer's portfolio.

HX 1108389-1Issued
Quality management systemNotified body: 0197Expiry: Jun 20, 2029