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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

161-001 — IVDR Class A IVDR by Sanowa PlastoTec GmbH

MD Atlas
Sanowa PlastoTec GmbH

EUDAMED last updated this device on Nov 14, 2025

161-001

4099853004A9

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Sanowa PlastoTec GmbH
UDI-DI code: 04099853003463
Reference / catalog number: 161-001

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Manufacturer information

Organization name: Sanowa PlastoTec GmbH
SRN: DE-MF-000040380
Manufacturer status: Active

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.

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: 04099853003463
Basic UDI-DI: 4099853004A9
Reference / catalog number: 161-001
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: 1000
Additional product description: —
Additional information URL: https://www.sanowa-plastotec.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W05030501INCLUSION DEVICES, CASSETTES

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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