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Bacterial McFarland Standard

EUDAMED

Class A (EU MDR)

Ref 105-058930-00Model Z3

by Hunan Mindray Medical Technology Co., Ltd.

Identity

Device Name
Bacterial McFarland Standard EUDAMED
Model / Reference
Z3 EUDAMED
105-058930-00 EUDAMED

Identifiers

Primary DI / UDI-DI
06938010902820 EUDAMED
Basic UDI-DI
69380109028205G 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

Yes

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 a398ebc0-725b-4c30-bf41-2331bc1befc2 61 fields · synced Oct 6, 2026