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D60

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref D60

by UV Smart Technologies B.V.

Identity

Trade Name
D60 EUDAMED
Device Name
UV Smart D60 EUDAMED
Model / Reference
D60 EUDAMED

Identifiers

Primary DI / UDI-DI
87193266342720 EUDAMED
Basic UDI-DI
87193266342D603Q EUDAMED
Direct Marketing DI
87193266342720 EUDAMED
EMDN Code
Z12011301 CLEANING AND DISINFECTION EQUIPMENT EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Netherlands 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

D60 by UV Smart Technologies B.V. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Similar devices

Also classified as Surgical utensil washer/disinfector.

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
NL-MF-000017126

Sources (2)

  • EUDAMED a7b160e6-56c8-4685-a5af-31e85b787c0c 61 fields · synced Jun 19, 2026
  • FDA 510(k) K251354 1 fields · synced May 18, 2026