Intraoral Scanner

by Changzhou Sifary Medical Technology Co., Ltd. EUDAMED

Withdrawn Not intended for the EU market

Ref 7680035Model Helios 500, Helios 620,Helios 630, Helios 640, Helios 650,Helios 660, Helios 670, MyScanner, SCAN-MI PRO

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number697259778EM002MJ Basic UDI-DI	Date29 Nov 2024Registered	StatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/MDR Withdrawn

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference: Helios 500, Helios 620, Helios 630, Helios 640, Helios 650, Helios 660, Helios 670, MyScanner, SCAN-MI PRO, 7680035

Primary DI / UDI-DI: 06941877812478
Basic UDI-DI: 697259778EM002MJ
Direct Marketing DI: 06941877812478
EMDN Code: Q010207 Dental impression devices for prosthetic dentistry

Device Class: Class I

Manufacturer details

EUDAMED SRN: CN-MF-000010405
Authorised representative: Caretechion GmbH DE-AR-000005946

Other devices from Changzhou Sifary Medical Technology Co., Ltd.

Endodontic Files

Class IIa
Intraoral Digital Imaging Sensor

Class IIa
Endodontic Files

Class IIa
Endodontic Files

Class IIa
Endodontic Files

Class IIa
Endodontic Files

Class IIa

See all devices from Changzhou Sifary Medical Technology Co., Ltd. →

Properties

Other properties (13)

Sterile: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No