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Tr

EUDAMED

Class I (EU MDR)

Ref 3015531303Model TF,TR,TC,FO,SF,SO,SR,RS,EX,BR,BC,DI,DI,WR,CR,CD,FG,RA,HP

by Zhaoqing Gaoyao Recende Medical Equipment Co., LTD

Identity

Trade Name
TR EUDAMED
Device Name
Dental Diamond Burs EUDAMED
Model / Reference
TF,TR,TC,FO,SF,SO,SR,RS,EX,BR,BC,DI,DI,WR,CR,CD,FG,RA,HP EUDAMED
3015531303 EUDAMED

Identifiers

Primary DI / UDI-DI
06975617282023 EUDAMED
Basic UDI-DI
697561728BURST9 EUDAMED
EMDN Code
Q010501 DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Netherlands 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

Yes

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Carbide dental bur, single-use

Tr by Zhaoqing Gaoyao Recende Medical Equipment Co., LTD — Class I — 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
Zhaoqing Gaoyao Recende Medical Equipment Co., LTD
EUDAMED SRN
CN-MF-000028095
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (1)

  • EUDAMED 241f2274-7015-406c-ad42-43653cc362cf 61 fields · synced Jun 18, 2026