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Huro Path® T

EUDAMED

Class A (EU MDR)

Ref ALBCCZ003

by CelltraZone Co., Ltd

Identity

Trade Name
HURO PATH® T EUDAMED
Device Name
Sample Processing Instruments EUDAMED
Model / Reference
ALBCCZ003 EUDAMED

Identifiers

Primary DI / UDI-DI
08800038500327 EUDAMED
Basic UDI-DI
88000385CZHUROQ9 EUDAMED
Direct Marketing DI
08800038500327 EUDAMED
EMDN Code
W02069099 VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Romania 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

Huro Path® T by CelltraZone 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
KR-MF-000026492
Authorised Representative
Javitech Consulting GmbH DE-AR-000045915

Sources (1)

  • EUDAMED 70f84d89-e507-483d-8980-c998b0119b87 61 fields · synced Jun 19, 2026