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Surgical Guide Resin SG01 1kg/bottle

EUDAMED

Class I (EU MDR)

Ref 0042Model SG01

by Hangzhou SHINING3D Dental Technology Co., Ltd.

Identity

Trade Name
Surgical Guide Resin SG01 1kg/bottle EUDAMED
Device Name
Surgical Guide Resin EUDAMED
Model / Reference
SG01 EUDAMED
0042 EUDAMED

Identifiers

Primary DI / UDI-DI
06975338700042 EUDAMED
Basic UDI-DI
697533870SG01NG EUDAMED
Direct Marketing DI
06975338700042 EUDAMED
EMDN Code
Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Netherlands 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

Surgical Guide Resin SG01 1kg/bottle by Hangzhou SHINING3D Dental Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000033456
Authorised Representative
Lotus NL B.V. NL-AR-000000121

Sources (1)

  • EUDAMED dd6ec862-4b48-4578-9b9f-1fc32cf69111 61 fields · synced Oct 6, 2026