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Dandy Vision Handpiece

EUDAMED

Class I (EU MDR)

Ref 6583579Model AS 100, AS 200E, AS 260, AS 260a, S300W, ST 200E, ST 300E, NeoScan 1000, NeoScan 2000, Owandy ios, Owandy ios Wireless, DI-1

by Alliedstar Medical Equipment Co., Ltd.

Identity

Trade Name
Dandy Vision Handpiece EUDAMED
Device Name
Intraoral Scanner EUDAMED
Model / Reference
AS 100, AS 200E, AS 260, AS 260a, S300W, ST 200E, ST 300E, NeoScan 1000, NeoScan 2000, Owandy ios, Owandy ios Wireless, DI-1 EUDAMED
6583579 EUDAMED

Identifiers

Primary DI / UDI-DI
06973993440327 EUDAMED
Basic UDI-DI
697399344alliedstar01SL EUDAMED
Direct Marketing DI
06973993440327 EUDAMED
EMDN Code
Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED

Classification

Device Class
Class I 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: Dental implant suprastructure, temporary, preformed, single-use

Dandy Vision Handpiece by Alliedstar Medical Equipment Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Dental implant suprastructure, temporary, preformed, single-use.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Alliedstar Medical Equipment Co., Ltd.
EUDAMED SRN
CN-MF-000008845
Authorised Representative
Etkon GmbH DE-AR-000009335

Sources (1)

  • EUDAMED 4f050e01-ded5-4027-8759-0b7fed5c29e9 61 fields · synced Jun 18, 2026