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Intraoral Scanner

EUDAMED

Class I (EU MDR)

Ref 7680039Model Helios 500, Helios 620,Helios 630, Helios 640, Helios 650,Helios 660, Helios 670, MyScanner, SCAN-MI PRO

by Changzhou Sifary Medical Technology Co., Ltd.

Identity

Trade Name
Intraoral Scanner EUDAMED
Device Name
Intraoral Scanner EUDAMED
Model / Reference
Helios 500, Helios 620,Helios 630, Helios 640, Helios 650,Helios 660, Helios 670, MyScanner, SCAN-MI PRO EUDAMED
7680039 EUDAMED

Identifiers

Primary DI / UDI-DI
06941877812515 EUDAMED
Basic UDI-DI
697259778EM002MJ EUDAMED
Direct Marketing DI
06941877812515 EUDAMED
EMDN Code
Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED

Classification

Device Class
Class I 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 Changzhou Sifary Medical Technology 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
Changzhou Sifary Medical Technology Co., Ltd.
EUDAMED SRN
CN-MF-000010405
Authorised Representative
Caretechion GmbH DE-AR-000005946

Sources (1)

  • EUDAMED 191034f8-3231-46cb-a3c7-dde0338aa351 61 fields · synced Jun 19, 2026