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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

6321 — IVDR Class A IVDR by Kallies Feinchemie AG

MD Atlas
Kallies Feinchemie AG

EUDAMED last updated this device on Aug 8, 2023

6321

426237586630028

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Kallies Feinchemie AG
UDI-DI code: 04262375860047
Reference / catalog number: 6321

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Manufacturer information

Organization name: Kallies Feinchemie AG
SRN: DE-MF-000025918
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

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: not provided
UDI-DI code: 04262375860047
Basic UDI-DI: 426237586630028
Reference / catalog number: 6321
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: Fixation for Gram-Staining
Additional information URL: https://www.feinchemie.de/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01030708STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)

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

Related devices

This device is not currently linked to any other device.

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.