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Ninjo

EUDAMED

Class IIa (EU MDR)

Ref FA1A021ECFR1Model FA0A011OAAT0

by ArjoHuntleigh AB

Identity

Trade Name
Ninjo EUDAMED
Device Name
NINJO EUDAMED
Model / Reference
FA0A011OAAT0 EUDAMED
FA1A021ECFR1 EUDAMED

Identifiers

Primary DI / UDI-DI
05059441147411 EUDAMED
Basic UDI-DI
5060693520037VW EUDAMED
EMDN Code
Z12011301 CLEANING AND DISINFECTION EQUIPMENT EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
France EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Surgical utensil washer/disinfector

Ninjo by Arjohuntleigh AB — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Surgical utensil washer/disinfector.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
ArjoHuntleigh AB
EUDAMED SRN
SE-MF-000000696

Sources (1)

  • EUDAMED 97cbbe34-8725-46ae-9283-0ff5534143b7 61 fields · synced Sep 17, 2026