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Bacterial McFarland Standard

EUDAMED

Class A (EU MDR)

Ref TDR-Z2

by Hunan Mindray Medical Technology Co., Ltd.

Identity

Device Name
Bacterial McFarland Standard EUDAMED
Model / Reference
TDR-Z2 EUDAMED

Identifiers

Primary DI / UDI-DI
06938010901762 EUDAMED
Basic UDI-DI
69380109017625L EUDAMED
EMDN Code
W01040699 CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Italy EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

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

Category: Multiple bacteria species culture isolate identification control IVD, kit

Bacterial McFarland Standard by Hunan Mindray Medical Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Multiple bacteria species culture isolate identification control IVD, kit.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Hunan Mindray Medical Technology Co., Ltd.
EUDAMED SRN
CN-MF-000022479
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

  • EUDAMED 6ef89767-0cc3-4031-b212-feac5b0260ae 61 fields · synced Oct 7, 2026