Identity
- Trade Name
- REFRACTOR FDA UDI
- Generic Name
- Phoropter FDA UDI
- Device Name
- The NIDEK REFRACTOR Model RT-5100 is a computerized refractor used for subjective refraction in connection with the NIDEK AUTO REFRACTOMETER (AR), AUTO REF/KERATOMETER (ARK), AUTO REF/KER/TONOMETER (RKT), or AUTO LENSMETER (LM). The RT-5100 includes a refractor head, control box, relay box, and printer. FDA UDI
- Model / Reference
- RT-5100 FDA UDI
- Description
- The NIDEK REFRACTOR Model RT-5100 is a computerized refractor used for subjective refraction in connection with the NIDEK AUTO REFRACTOMETER (AR), AUTO REF/KERATOMETER (ARK), AUTO REF/KER/TONOMETER (RKT), or AUTO LENSMETER (LM). The RT-5100 includes a refractor head, control box, relay box, and printer. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669100820 FDA UDI
- FDA Product Code
- HKN FDA UDI
- GMDN Term
- Phoropter FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1770 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: Phoropter
Refractor by Nidek, 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
- Nidek, Inc.
Sources (1)
- FDA UDI fe729852-a220-49f0-9250-1b632f54d24a 34 fields · synced May 30, 2026