← Back to catalogue
EyeMax2
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref R300P03-004Model EyeMax 2 Preemie 20 pack
by Maxtec, Inc.
Identity
- Trade Name
- EyeMax 2 Micro 20/pack Italian EUDAMEDEyeMax2 FDA UDI
- Generic Name
- Phototherapy infant blanket FDA UDI
- Device Name
- EyeMax 2 EUDAMEDEyeMax2 Micro 20/Pack Italian (Italian Label) FDA UDI
- Model / Reference
- EyeMax 2 Preemie 20 pack EUDAMEDR300P03-004 EUDAMEDMicro FDA UDI
- Description
- EyeMax2 Micro 20/Pack Italian (Italian Label) FDA UDI
Identifiers
- Catalog Number
- R300P03-004 FDA UDI
- Primary DI / UDI-DI
- 00817770025818 EUDAMEDFDA UDI
- Basic UDI-DI
- 081777002EyeMax2CU EUDAMED
- Direct Marketing DI
- 00817770025818 EUDAMED
- FDA Product Code
- FOK FDA UDI
- EMDN Code
- V0201 PHOTOTHERAPY MASKS EUDAMED
- GMDN Term
- Phototherapy infant blanket 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Phototherapy infant blanket
EyeMax2 by Maxtec, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Phototherapy infant blanket.
- EyeMax2 — Maxtec, Inc. · Class I
- EyeMax2 — Maxtec, Inc. · Class I
- EyeMax2 — Maxtec, Inc. · Class I
- EyeMax2 — Maxtec, Inc. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Maxtec, Inc.
Sources (2)
- FDA UDI bbcbf6ee-efb9-46f1-a2a1-e3671f4b6b2d 34 fields · synced Jun 19, 2026
- EUDAMED a267bc2d-4bcd-4c6e-a682-6510f426de60 61 fields · synced Jun 19, 2026