NeoShades® with Tabs Phototherapy Eye Shields - Micro Plain
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- NeoShades® with Tabs Phototherapy Eye Shields - Micro Plain 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® EUDAMEDN720PL EUDAMEDMicro Plain 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
- N720PL FDA UDI
- Primary DI / UDI-DI
- 10812594013109 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Phototherapy eye protector, reusable
NeoShades® with Tabs Phototherapy Eye Shields - Micro Plain by Neotech Products LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Phototherapy eye protector, reusable.
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- Neonatal Phototherapy Eye Mask — Unimed Medical Supplies, Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 b78bfdcd-cb98-4bda-ac45-92ab9ac2d814 61 fields · synced Jun 18, 2026
- FDA UDI 21ff1fcc-a729-4308-99b5-69639a5109c6 34 fields · synced May 30, 2026