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EyeMax2
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref R300P02Model EyeMax 2 Preemie 20 pack
by Maxtec, Inc.
Identity
- Trade Name
- EyeMax 2 Preemie EUDAMEDEyeMax2 FDA UDI
- Generic Name
- Phototherapy eye protector, reusable FDA UDI
- Device Name
- EyeMax 2 EUDAMEDPreemie 20/pack FDA UDI
- Model / Reference
- R300P02 EUDAMEDFDA UDIEyeMax 2 Preemie 20 pack EUDAMED
- Description
- Preemie 20/pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817770021834 EUDAMEDFDA UDI
- Basic UDI-DI
- 081777002EyeMax2CU EUDAMED
- Direct Marketing DI
- 00817770021834 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.
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- 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 d79a9011-82c5-4b7a-bfc7-dcf0564c1111 33 fields · synced Jun 11, 2026
- EUDAMED 60b97c14-dcea-4351-81dc-7928c4f34c7c 61 fields · synced Jun 11, 2026