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EyeMax2
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref R300P01Model EyeMax 2 Regular
by Maxtec, Inc.
Identity
- Trade Name
- EyeMax 2 Regular EUDAMEDEyeMax2 FDA UDI
- Generic Name
- Phototherapy eye protector, reusable FDA UDI
- Device Name
- EyeMax 2 EUDAMEDRegular 20/pack FDA UDI
- Model / Reference
- R300P01 EUDAMEDFDA UDIEyeMax 2 Regular EUDAMED
- Description
- Regular 20/pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00853061006920 EUDAMEDFDA UDI
- Basic UDI-DI
- 0853061006EyeMax22V EUDAMED
- Direct Marketing DI
- 00853061006920 EUDAMED
- FDA Product Code
- FOK FDA UDI
- EMDN Code
- V0201 PHOTOTHERAPY MASKS EUDAMED
- GMDN Term
- Phototherapy eye protector, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5270 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Phototherapy eye protector, reusable
EyeMax2 by Maxtec, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, 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
- PHOTOTHERAPY MASKS (Pack of 50) — GINEVRI srl · 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Maxtec, Inc.
Sources (2)
- FDA UDI ccb2fe7e-d245-4885-89b2-307d88e963d8 33 fields · synced Jul 25, 2026
- EUDAMED 1012f994-4f38-4d62-9b1a-4269c1db989b 61 fields · synced Jul 25, 2026