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Round head cone type

EUDAMED

Class I (EU MDR)

Ref TR-S13Model Flat head cone type, Round head cone type, Pointed truncated cone type, Flame pointed head type, Flat head cylindrical type, Round head inverted cone type, Round ball type, etc

by Foshan Qiyang Medical Equipment Limited

Identity

Trade Name
Round head cone type EUDAMED
Device Name
Diamond Burs EUDAMED
Model / Reference
Flat head cone type, Round head cone type, Pointed truncated cone type, Flame pointed head type, Flat head cylindrical type, Round head inverted cone type, Round ball type, etc EUDAMED
TR-S13 EUDAMED

Identifiers

Primary DI / UDI-DI
16977290910375 EUDAMED
Basic UDI-DI
697729091DiamondBursSV EUDAMED
EMDN Code
Q010501 DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Austria EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

Yes

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: Carbide dental bur, single-use

Round head cone type by Foshan Qiyang Medical Equipment Limited — Class I — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Carbide dental bur, single-use.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Foshan Qiyang Medical Equipment Limited
EUDAMED SRN
CN-MF-000040233
Authorised Representative
Sungo Cert GmbH DE-AR-000010869

Sources (1)

  • EUDAMED bab6c1bb-0d48-4cf6-b837-8205966b42cf 61 fields · synced Oct 6, 2026