Dental treatment unit

EUDAMED

Class IIa (EU MDR)

Ref KLT-6220Model KLT-6220 Serial Number: A3S

by Foshan Roson Medical Instruments Co., Ltd

Identity

Trade Name: Dental treatment unit EUDAMED
Device Name: Dental treatment unit EUDAMED
Model / Reference: KLT-6220 Serial Number: A3S EUDAMED
KLT-6220 EUDAMED

Identifiers

Primary DI / UDI-DI: 06970940030334 EUDAMED
Basic UDI-DI: B-06970940030334 EUDAMED
EMDN Code: Z12110101 DENTAL TREATMENT UNITS EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Spain EUDAMED

Clinical & Handling

Sterile

EUDAMED

Implantable

EUDAMED

Reusable

Yes

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Category: Dental delivery system

Dental treatment unit by Foshan Roson Medical Instruments Co., Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

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Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-06970940030334	Class IIa	Active

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Manufacturer

Manufacturer: Foshan Roson Medical Instruments Co., Ltd
EUDAMED SRN: CN-MF-000024527
Authorised Representative: Wellkang Ltd XI-AR-000001836

Sources (1)

EUDAMED dc8b823d-3d5e-4f26-9872-03fcb33f5e9c 61 fields · synced Jun 18, 2026