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Aquasoothe 1% 500g

EUDAMED

Class I (EU MDR)

Ref AQUA1CREAM500GRAMModel Thirty:30 125g

by Ennogen Healthcare Ltd

Identity

Trade Name
Aquasoothe 1% 500g EUDAMED
Device Name
Thirty:30 125g EUDAMED
Model / Reference
Thirty:30 125g EUDAMED
AQUA1CREAM500GRAM EUDAMED

Identifiers

Primary DI / UDI-DI
05060254920207 EUDAMED
Basic UDI-DI
506025492EmollientsP3 EUDAMED
EMDN Code
M9002 PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS) EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Northern Ireland 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

Aquasoothe 1% 500g by Ennogen Healthcare 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
GB-MF-000022280
Authorised Representative
Elara Pharmaservices Europe Ltd IE-AR-000011852

Sources (1)

  • EUDAMED b0bdba4a-677e-41ee-bf38-e14938de224b 61 fields · synced Oct 6, 2026