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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 Karnovsky — IVDR Class A IVDR by biocyc Biotechnologie…

MD Atlas
biocyc Biotechnologie GmbH & Co. KG

EUDAMED last updated this device on Sep 14, 2023

Q Fix Karnovsky

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: 04255597800502
Reference / catalog number: FX-005-1000

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Manufacturer information

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

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

CW082
EUDAMED did not publish a description for this code.
CW083
EUDAMED did not publish a description for this code.
CW084
EUDAMED did not publish a description for this code.
CW088
EUDAMED did not publish a description for this code.
CW089
EUDAMED did not publish a description for this code.
CW090
EUDAMED did not publish a description for this code.
CW093
EUDAMED did not publish a description for this code.
CW094
EUDAMED did not publish a description for this code.
CW106
EUDAMED did not publish a description for this code.
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.
CW999
P305 + P351 + P338
CW999
P310
CW999
P312
CW999
P362 + P364

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 Karnovsky
UDI-DI code: 04255597800502
Basic UDI-DI: 42555978FIXATIONDF
Reference / catalog number: FX-005-1000
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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Software identification