Identity
- Trade Name
- Welch Allyn, Inc. FDA UDI
- Generic Name
- Automated ophthalmic refractometer FDA UDI
- Device Name
- Welch Allyn SureSight Vision Screener; Automatically screens for common vision problems, including near and farsightedness (myopia/hyperopia), astigmatism (asymmetrical focus), and anisometropia (unequal power between eyes); Left/Right Difference Mode, Charging Base; 120 V, 60 Hz AC, Lithium-Ion (#72420) Battery; IEC Plug Type-B FDA UDI
- Model / Reference
- 901029 FDA UDI
- Description
- Welch Allyn SureSight Vision Screener; Automatically screens for common vision problems, including near and farsightedness (myopia/hyperopia), astigmatism (asymmetrical focus), and anisometropia (unequal power between eyes); Left/Right Difference Mode, Charging Base; 120 V, 60 Hz AC, Lithium-Ion (#72420) Battery; IEC Plug Type-B FDA UDI
Identifiers
- Catalog Number
- 14000 FDA UDI
- Primary DI / UDI-DI
- 00732094088441 FDA UDI
- FDA Product Code
- HKO FDA UDI
- GMDN Term
- Automated ophthalmic refractometer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1760 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Welch Allyn, Inc. by Welch Allyn, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Welch Allyn, Inc.
Sources (1)
- FDA UDI 97007236-91b1-4d2c-9361-cbbb49751b62 36 fields · synced May 30, 2026