Identity
- Trade Name
- TearCheck T FDA UDI
- Generic Name
- Corneal topography system analyser FDA UDI
- Model / Reference
- V040US000A08A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03662824001846 FDA UDI
- FDA Product Code
- MMQ FDA UDI
- GMDN Term
- Corneal topography system analyser FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Corneal topography system analyser
TearCheck T by E-Swin — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- E-Swin
Sources (1)
- FDA UDI 2360964a-4f5f-4cb5-a5e8-7b49c6193d4c 33 fields · synced May 30, 2026