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Intraoral Scanner

EUDAMED

Class I (EU MDR)

Ref 6583391Model 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
Intraoral Scanner 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
6583391 EUDAMED

Identifiers

Primary DI / UDI-DI
06973993442215 EUDAMED
Basic UDI-DI
697399344alliedstar01SL EUDAMED
EMDN Code
Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Austria 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

Intraoral Scanner 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 64c86e53-932b-4304-bf9b-5bc1f0daee7a 61 fields · synced Jun 11, 2026