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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

TMB Substrate — IVDR Class A IVDR by AliveDx Suisse SA

MD Atlas
AliveDx Suisse SA

EUDAMED last updated this device on Oct 1, 2024

TMB Substrate

764032746MOSAIQSYSTEMVQ

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: AliveDx Suisse SA
UDI-DI code: 07640327465125
Reference / catalog number: 155050

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Manufacturer information

Organization name: AliveDx Suisse SA
SRN: CH-MF-000024025
Manufacturer status: Active

Critical warnings

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

CW011
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Netherlands; available across 1 country total.

Placed on the market in Netherlands; per-country availability dates not published.

Device identification

Trade name: TMB Substrate
UDI-DI code: 07640327465125
Basic UDI-DI: 764032746MOSAIQSYSTEMVQ
Reference / catalog number: 155050
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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

Conjugate HRP764032746MOSAIQSYSTEMVQOn the market Detection Reagent 1764032746MOSAIQSYSTEMVQOn the market 155007764032746MOSAIQSYSTEMVQOn the market 155008764032746MOSAIQSYSTEMVQOn the market IgA Conjugate764032746MOSAIQSYSTEMVQOn 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.