← Back to catalogue
Phototherapy Eye Mask Large
EUDAMEDClass I (EU MDR)
Ref 13678B73Model PHOTOTHERAPY EYE MASK SMALL
by GINEVRI srl
Identity
- Trade Name
- PHOTOTHERAPY EYE MASK LARGE EUDAMED
- Device Name
- PHOTOTHERAPY EYE MASK EUDAMED
- Model / Reference
- PHOTOTHERAPY EYE MASK SMALL EUDAMED13678B73 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053847360464 EUDAMED
- Basic UDI-DI
- 80538473632SM EUDAMED
- Direct Marketing DI
- 08053847360464 EUDAMED
- EMDN Code
- V0201 PHOTOTHERAPY MASKS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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: Phototherapy eye protector, reusable
Phototherapy Eye Mask Large by GINEVRI srl — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Phototherapy eye protector, reusable.
- NeoShades® with Headstrap Phototherapy Eye Shields - Micro Plain — Neotech Products LLC · Class I
- NeoShades® with Tabs Phototherapy Eye Shields - Small Plain — Neotech Products LLC · Class I
- Sahil Surgical (Pvt) Ltd — Sahil Surgical (Pvt) Ltd. · Class I
- EyeMax2 — Maxtec, Inc. · Class I
- VER-FIX Dwuczęściowe okularki do fototerapii — SINMED SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ · Class I
- WeeSpecs Supreme, Medium, 50/pk — INTERNATIONAL BIOMEDICAL, LTD. · Class I
- Phototherapy Eye Band Large — Dilamed Tıbbi Ürünler Sanayi ve Ticaret A.Ş. · Class I
- VER-FIX Jednoczęściowe okularki do fototerapii — SINMED SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 80538473632SM | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GINEVRI srl
- EUDAMED SRN
- IT-MF-000034527
Sources (1)
- EUDAMED e3d00e35-b8b2-4626-89d7-52b76b71f650 61 fields · synced Jul 20, 2026