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Curing Light

EUDAMED

Class I (EU MDR)

Ref i-Cure ProModel i-cure, i-cure pro, i-cure corded, Q5, Q6, Q6 corded, Q7, Q8, Q8 Pro, Q9, TQ8, IQ8,Dolphin, Dolphin corded

by Guilin Mecco Medical Instrument Co., Ltd.

Identity

Trade Name
Curing Light EUDAMED
Device Name
Curing Light EUDAMED
Model / Reference
i-cure, i-cure pro, i-cure corded, Q5, Q6, Q6 corded, Q7, Q8, Q8 Pro, Q9, TQ8, IQ8,Dolphin, Dolphin corded EUDAMED
i-Cure Pro EUDAMED

Identifiers

Primary DI / UDI-DI
06973751060248 EUDAMED
Basic UDI-DI
697375106RCLTK EUDAMED
EMDN Code
Z12119003 COLD LIGHT DENTAL EQUIPMENT 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/surgical polymerization lamp

Curing Light by Guilin Mecco Medical Instrument Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Dental/surgical polymerization lamp.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Guilin Mecco Medical Instrument Co., Ltd.
EUDAMED SRN
CN-MF-000019910
Authorised Representative
Share info GmbH DE-AR-000005132

Sources (1)

  • EUDAMED 7aaa1683-19e3-466d-8826-b4c816379640 61 fields · synced Jul 8, 2026