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Transport Mediums

EUDAMED

Class A (EU MDR)

Ref MT-DTM001 Model "MT-DTM001,MT-DTM002; MT-HTM001,MT-HTM002; MT-IVT001,MT-IVT002,MT-SVT001,MT-SVT002; MT-CTM001; MT-LAT001,MT-LAT002; MT-FTM001,MT-FTM002,MT-FTM003;"

by Shenzhen MandeLab Co., Ltd.

Identity

Device Name
Transport Mediums EUDAMED
Model / Reference
"MT-DTM001,MT-DTM002; MT-HTM001,MT-HTM002; MT-IVT001,MT-IVT002,MT-SVT001,MT-SVT002; MT-CTM001; MT-LAT001,MT-LAT002; MT-FTM001,MT-FTM002,MT-FTM003;" EUDAMED
MT-DTM001 EUDAMED

Identifiers

Primary DI / UDI-DI
06974760785016 EUDAMED
Basic UDI-DI
697476078MediumsAS EUDAMED
EMDN Code
W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Austria 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

No

EUDAMED

New Device

No

EUDAMED

Transport Mediums by Shenzhen Mandelab 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-000009021
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (1)

  • EUDAMED 41375241-c0fa-41c6-ba68-fbcbc0636536 61 fields · synced Jul 10, 2026