En

by Aidite（Qinhuangdao）Technology Co., Ltd. China EUDAMED

Ref 98×16-Multilayer-3DModel 65×25×22-Multilayer-3D EMDN Q01010101

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD	Number697844793ZCM35 Basic UDI-DI	Date28 May 2026Registered	StatusActive
European Union	CE/MDR	Number697844793ZCM35 Basic UDI-DI	Date28 May 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/MDD, CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name: En
Dental Zirconia Ceramic
Model / Reference: 65×25×22-Multilayer-3D, 98×16-Multilayer-3D

Primary DI / UDI-DI: 06970469233544
Basic UDI-DI: 697844793ZCM35, B-06970469233544
EMDN Code: Q01010101, Q01010199

Device Class: Class IIa
Market of Registration: Germany

Manufacturer details

EUDAMED SRN: CN-MF-000015573
Authorised representative: AIDITE Europe GmbH DE-AR-000048785

Other devices from Aidite（Qinhuangdao）Technology Co., Ltd.

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Class IIa
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Class IIa
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Class IIa
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Class IIa
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Class IIa

See all devices from Aidite（Qinhuangdao）Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records

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

Sources (2)

EUDAMED 95eabff7-d5a7-4b36-a9df-c029f364001d 61 fields · synced 22 Oct 2026
EUDAMED 06970469233544|B-06970469233544 61 fields · synced 8 Oct 2026