EPIMAX Isomol Gel 100g

by Aspire Pharma Limited

Ref 1010456

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number506020973APL016TZ7A Basic UDI-DI	Date18 May 2026Registered	StatusActive

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: EPIMAX Isomol Gel
Model / Reference: 1010456

Primary DI / UDI-DI: 05060209732428
Basic UDI-DI: 506020973APL016TZ7A
Direct Marketing DI: 05060209732428
EMDN Code: V9099 Various devices not included in other classes - other

Device Class: Class I
Market of Registration: Northern Ireland

Manufacturer details

EUDAMED SRN: UK-MF-000051805
Authorised representative: APIE Limited IE-AR-000050724

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Properties

Other properties (13)

Sterile: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No