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Transport Track Module, Model: TX

EUDAMED

Class A (EU MDR)

Ref LX0255Model iTLA Max

by Shenzhen Yhlo Biotech Co., Ltd.

Identity

Trade Name
Transport Track Module, Model: TX EUDAMED
Device Name
Intelligent Total Laboratory Automation EUDAMED
Model / Reference
iTLA Max EUDAMED
LX0255 EUDAMED

Identifiers

Primary DI / UDI-DI
06925912737117 EUDAMED
Basic UDI-DI
692591270286HX EUDAMED
EMDN Code
W02060101 AUTOMATED SYSTEMS FOR THE MANAGEMENT OF PRE AND POST-ANALYSIS EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

Yes

EUDAMED

New Device

No

EUDAMED

Transport Track Module, Model: TX by Shenzhen Yhlo Biotech Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

EUDAMED SRN
CN-MF-000001137
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

  • EUDAMED ab7192c5-6ec4-4c72-b9c3-17aee7a61f72 61 fields · synced Jul 26, 2026