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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

simplix stool sample preperation… — IVDR Class A IVDR

MD Atlas
GAUDLITZ PLASTIC TECHNOLOGIES GmbH & Co.KG

EUDAMED last updated this device on Dec 13, 2023

simplix stool sample preperation system unfilled

9561648T1860WR

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: GAUDLITZ PLASTIC TECHNOLOGIES GmbH & Co.KG
UDI-DI code: 04262443270129
Reference / catalog number: T0001860-02-00-65

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Manufacturer information

Organization name: GAUDLITZ PLASTIC TECHNOLOGIES GmbH & Co.KG
SRN: DE-MF-000038888
Manufacturer status: Active

Related devices

simplix stool sample preperation system unfille9561648T1860WROn the market simplix stool sample preperation system unfilled9561648T1860WROn the market simplix stool sample preperation system unfilled9561648T1860WROn the market simplix stool sample preperation system unfilled9561648T1860WROn the market simplix stool preperation system unfilled9561648T1860WROn 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: simplix stool sample preperation system unfilled
UDI-DI code: 04262443270129
Basic UDI-DI: 9561648T1860WR
Reference / catalog number: T0001860-02-00-65
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)

W05019001FAECES COLLECTION DEVICES

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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