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Orthodontic Elastics

EUDAMED

Class IIa (EU MDR)

Ref Y-O61164Model Power Chains

by Zhejiang Yo Medical Technology Co., Ltd

Identity

Device Name
ORTHODONTIC ELASTICS EUDAMED
Model / Reference
Power Chains EUDAMED
Y-O61164 EUDAMED

Identifiers

Primary DI / UDI-DI
06923733205051 EUDAMED
Basic UDI-DI
69237332YOTLL0001V7 EUDAMED
EMDN Code
Q010404 ORTHODONTIC ELASTICS, CHAINS AND SPRINGS EUDAMED

Classification

Device Class
Class IIa 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: Orthodontic retainer

Orthodontic Elastics by Zhejiang Yo Medical Technology Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic retainer.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000040822
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (1)

  • EUDAMED 082ed12e-54eb-4c8b-a1eb-5daf695bdd11 61 fields · synced Jun 18, 2026