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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

SB-0008b-15 — IVDR Class A IVDR by ZytoVision GmbH

MD Atlas
ZytoVision GmbH

EUDAMED last updated this device on Mar 24, 2026

SB-0008b-15

4250380S618K

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: ZytoVision GmbH
UDI-DI code: 04250380308739
Reference / catalog number: SB-0008b-15

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Manufacturer information

Organization name: ZytoVision GmbH
SRN: DE-MF-000024390
Manufacturer status: Active

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AB-0001-44250380S178GOn the market Z-2116-504250380P163R2On the market Z-2105-504250380P152QVOn the market Z-2100-504250380P147R4On the market NOA-2034250380P417RAOn the market

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
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: 04250380308739
Basic UDI-DI: 4250380S618K
Reference / catalog number: SB-0008b-15
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)

W0580IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Software identification