Identity
- Trade Name
- MediWorks FDA UDI
- Generic Name
- Hand-held subjective ophthalmic refractometer FDA UDI
- Device Name
- The vision screening instrument is based on the principle of eccentric photo refraction and is used for screening myopia, hyperopia and astigmatism. Refraction, eye position, pupil, pupil distance and other information can be obtained for doctors to diagnose eye diseases. FDA UDI
- Model / Reference
- V101 FDA UDI
- Description
- The vision screening instrument is based on the principle of eccentric photo refraction and is used for screening myopia, hyperopia and astigmatism. Refraction, eye position, pupil, pupil distance and other information can be obtained for doctors to diagnose eye diseases. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945087500064 FDA UDI
- FDA Product Code
- HKO FDA UDI
- GMDN Term
- Hand-held subjective ophthalmic refractometer 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hand-held subjective ophthalmic refractometer
MediWorks by Shanghai Mediworks Precision Instruments Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hand-held subjective ophthalmic refractometer.
- MOPTIM — Shenzhen CERTAINN Technology Co., Ltd. · Class I
- MediWorks — SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO., LTD. · 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
- Shanghai Mediworks Precision Instruments Co., Ltd.
Sources (1)
- FDA UDI 3af79022-9e55-4dd0-911e-1f1b90be68c6 33 fields · synced May 31, 2026