Identity
- Trade Name
- andorate® Eye Cornea Protectors EUDAMEDFDA UDI
- Generic Name
- Eye patch FDA UDI
- Device Name
- Eye Cornea Protectors EUDAMED
- Model / Reference
- GAR001 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04897106953646 EUDAMEDFDA UDI
- Basic UDI-DI
- 489710695GAR001F4 EUDAMED
- FDA Product Code
- HMP FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Eye patch FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4440 FDA UDI
- Market of Registration
- Ireland 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
No
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
No
Category: Device sterilization/disinfection container, reusable
andorate® Eye Cornea Protectors by Ga Health Company Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 489710695GAR001F4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- GA Health Company Limited
- EUDAMED SRN
- HK-MF-000019784
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED f6bd2489-bcfd-45c4-81fb-4edfc28a14c1 61 fields · synced Jul 19, 2026
- FDA UDI 52ace984-b812-46c6-adc0-27d0f216e498 32 fields · synced May 30, 2026