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My Mask-E

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref MY MASK-E/PSN

by Espansione Marketing Spa

Identity

Trade Name
MY MASK-E EUDAMEDFDA UDI
Generic Name
Multi-modality skin surface treatment system FDA UDI
Device Name
Device for phototherapy in ophthalmology EUDAMED
Model / Reference
MY MASK-E/PSN EUDAMED
MY MASK-E/M500 FDA UDI

Identifiers

Catalog Number
MY MASK-E/M500 FDA UDI
Primary DI / UDI-DI
08056389703508 EUDAMED
08056389700392 FDA UDI
Basic UDI-DI
80563897MYMASKEEVO00UX EUDAMED
FDA Product Code
IRT FDA UDI
EMDN Code
Z12120299 THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER EUDAMED
GMDN Term
Multi-modality skin surface treatment system FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
890.5740 FDA UDI
Market of Registration
Italy EUDAMED
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

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

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

My Mask-E by Espansione Marketing Spa — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Espansione Marketing Spa

Sources (2)

  • FDA UDI e9ebfb09-2c89-4367-8feb-4deeb4bdc1ba 34 fields · synced Jul 23, 2026
  • EUDAMED 3db73453-d511-46ec-8986-bbcbbec3ba5a 61 fields · synced Jul 23, 2026