Identity
- Trade Name
- andorate® Eye Cornea Protectors FDA UDI
- Generic Name
- Eye patch FDA UDI
- Model / Reference
- GAR001-NP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14897106953650 FDA UDI
- FDA Product Code
- HMP FDA UDI
- GMDN Term
- Eye patch FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4440 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Category: Eye patch
andorate® Eye Cornea Protectors by GA Health Company Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Eye patch.
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- Optego — Optego Vision USA, Inc. · Class I
- Sharn Inc — Sharn Anesthesia · Class I
- iPRO — FANNIN (UK) LIMITED · Class I
- Optego — Optego Vision USA, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- GA Health Company Limited
Sources (1)
- FDA UDI 96df97c6-92cf-4cde-b4b5-d7f832263a07 32 fields · synced Jun 6, 2026