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Hu-Friedy

EUDAMED

Class I (EU MDR)

Ref CTNBB27/29Model Dental Device

by Hu-Friedy Manufacturing Co., LLC

Identity

Trade Name
Hu-Friedy EUDAMED
Model / Reference
Dental Device EUDAMED
CTNBB27/29 EUDAMED

Identifiers

Primary DI / UDI-DI
10889950147761 EUDAMED
Basic UDI-DI
0889950Place1RU EUDAMED
EMDN Code
Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Germany 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 composite resin

Hu-Friedy by Hu-Friedy Manufacturing Co., LLC — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Dental composite resin.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
US-MF-000017104
Authorised Representative
Hu-Friedy Europe LLC & Co. KG DE-AR-000005530

Sources (1)

  • EUDAMED c77a3f60-5a45-4174-aceb-eb3df9dd9222 61 fields · synced Jun 18, 2026