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HydraFacial

EUDAMED

Class I (EU MDR)

Ref 70301Model 74111

by Hydrafacial, LLC

Identity

Trade Name
HydraFacial EUDAMED
Device Name
HydroPeel Tip, Large Clear EUDAMED
Model / Reference
74111 EUDAMED
70301 EUDAMED

Identifiers

Primary DI / UDI-DI
00810007533797 EUDAMED
Basic UDI-DI
081000753TIP9V EUDAMED
EMDN Code
Z12040299 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
France 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: Dermatological laser beam guiding handpiece

HydraFacial by Hydrafacial LLC — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Dermatological laser beam guiding handpiece.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Hydrafacial, LLC
EUDAMED SRN
US-MF-000004431
Authorised Representative
E C REP LIMITED IE-AR-000003995

Sources (1)

  • EUDAMED 47e2d415-7045-4d6a-8e90-26ab477af08c 61 fields · synced May 22, 2026