Identity
- Trade Name
- Welch Allyn, Inc. FDA UDI
- Generic Name
- Vision physiology/eye movement analysis system FDA UDI
- Device Name
- Welch Allyn SureSight Autorefractor; Automatically screens for common vision problems, including near and farsightedness (myopia/hyperopia), astigmatism (asymmetrical focus), and anisometropia (unequal power between eyes); Degree in Axis Readings, Charging Base, Thermal Printer, Storage Case; 230 V, 50 Hz AC, Lithium-Ion (#72420) Battery; IEC Plug FDA UDI
- Model / Reference
- 901029 FDA UDI
- Description
- Welch Allyn SureSight Autorefractor; Automatically screens for common vision problems, including near and farsightedness (myopia/hyperopia), astigmatism (asymmetrical focus), and anisometropia (unequal power between eyes); Degree in Axis Readings, Charging Base, Thermal Printer, Storage Case; 230 V, 50 Hz AC, Lithium-Ion (#72420) Battery; IEC Plug FDA UDI
Identifiers
- Catalog Number
- 14012 FDA UDI
- Primary DI / UDI-DI
- 00732094088267 FDA UDI
- FDA Product Code
- HKO FDA UDI
- GMDN Term
- Vision physiology/eye movement analysis system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1760 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
Yes
FDA UDI
Category: Vision physiology/eye movement analysis system
Welch Allyn, Inc. by Welch Allyn, Inc. — 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
- Welch Allyn, Inc.
Sources (1)
- FDA UDI cb51608c-1da9-4bb3-a9b2-44229f0a46ae 35 fields · synced Jun 1, 2026