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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

131601 — IVDR Class A IVDR by Gold Standard…

MD Atlas
Gold Standard Diagnostics Frankfurt GmbH

EUDAMED last updated this device on Nov 13, 2024

131601

++ENTI131X01V025S

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Gold Standard Diagnostics Frankfurt GmbH
UDI-DI code: +ENTI13160108
Reference / catalog number: 131601

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Manufacturer information

Organization name: Gold Standard Diagnostics Frankfurt GmbH
SRN: DE-MF-000025020
Manufacturer status: Active

Critical warnings

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

CW043
EUDAMED did not publish a description for this code.
CW083
EUDAMED did not publish a description for this code.
CW067
EUDAMED did not publish a description for this code.
CW167
EUDAMED did not publish a description for this code.
CW306
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: +ENTI13160108
Basic UDI-DI: ++ENTI131X01V025S
Reference / catalog number: 131601
Issuing entity: HIBCC

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)

W0105900201BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC

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

141101++ENTI141101V03NWOn the market 131301++ENTI131X01V025SOn the market WE400.42++ENTIWE400X2V02LTOn the market 131101++ENTI131X01V025SOn the market WE400.62++ENTIWE400X2V02LTOn 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.