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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

SP-PLATE-C — IVDR Class A IVDR by Seramun Diagnostica GmbH

MD Atlas
Seramun Diagnostica GmbH

EUDAMED last updated this device on May 8, 2026

SP-PLATE-C

4099466SPPLATEEZ

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Seramun Diagnostica GmbH
UDI-DI code: 04099466360113
Reference / catalog number: SP-PLATE-C

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Manufacturer information

Organization name: Seramun Diagnostica GmbH
SRN: DE-MF-000026029
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW011
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04099466360113
Basic UDI-DI: 4099466SPPLATEEZ
Reference / catalog number: SP-PLATE-C
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: Device for image acquisition of Sera Spot® tests in 96-well microtiter plates.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0299IVD INSTRUMENTS - 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

Related devices

SP-PLATE-D4099466SPPLATEEZOn the market SP-SCAN-A4099466SPSCAN8UOn the market ACS-0024099466ACS002NYOn the market SP-WELL-A4099466SPWELLAXOn the market ACS-0014099466ACS001NWOn the market

Certificates

Certificate health across this manufacturer's portfolio.

HX 1624072-1Supplemented
Quality management systemNotified body: 0197Expiry: Oct 8, 2029