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NeoShades® with Tabs Phototherapy Eye Shields - Large
EUDAMEDFDA UDIClass I (EU MDR)
Ref N726Model NeoShades®
Identity
- Trade Name
- NeoShades® with Tabs Phototherapy Eye Shields - Large EUDAMEDNeoShades® with Tabs FDA UDI
- Generic Name
- Eye mask FDA UDI
- Device Name
- NeoShades® EUDAMEDThe NeoShades are indicated for use as eye protection during phototherapy sessions. They are intended for use on pediatric (neonates, infants and children) patients. FDA UDI
- Model / Reference
- NeoShades® EUDAMEDN726 EUDAMEDLarge with Ocular Pockets FDA UDI
- Description
- The NeoShades are indicated for use as eye protection during phototherapy sessions. They are intended for use on pediatric (neonates, infants and children) patients. FDA UDI
Identifiers
- Catalog Number
- N726 FDA UDI
- Primary DI / UDI-DI
- 10812594010979 EUDAMEDFDA UDI
- Basic UDI-DI
- 081259401N72000M5 EUDAMED
- FDA Product Code
- FOK FDA UDI
- EMDN Code
- V0201 PHOTOTHERAPY MASKS EUDAMED
- GMDN Term
- Eye mask FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5270 FDA UDI
- Market of Registration
- Germany 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Phototherapy eye protector, reusable
NeoShades® with Tabs Phototherapy Eye Shields - Large by Neotech Products LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Phototherapy eye protector, reusable.
- Sahil Surgical (Pvt) Ltd — Sahil Surgical (Pvt) Ltd. · Class I
- PHOTOTHERAPY MASKS (Pack of 50) — GINEVRI srl · 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
- Neonatal Phototherapy Eye Mask — Unimed Medical Supplies, Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081259401N72000M5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Neotech Products LLC
- EUDAMED SRN
- US-MF-000001895
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 679fdd59-cabc-431a-a6b7-198b4e2a883c 61 fields · synced Jun 19, 2026
- FDA UDI 0a7c544c-ab97-4f16-9ae7-2e550a3c17dd 34 fields · synced May 30, 2026