Identity
- Trade Name
- ri-scope® retinoscope head slit XL 3.5 V FDA UDI
- Generic Name
- Retinoscope, battery-powered FDA UDI
- Device Name
- The slit/spot retinoscopes (also known as skiascopes) are produced to determine the refraction (ametropias) of the eye. FDA UDI
- Model / Reference
- 10544 FDA UDI
- Description
- The slit/spot retinoscopes (also known as skiascopes) are produced to determine the refraction (ametropias) of the eye. FDA UDI
Identifiers
- Catalog Number
- 10544 FDA UDI
- Primary DI / UDI-DI
- 04045396010819 FDA UDI
- 510(k) Number
- K964338 FDA UDI
- FDA Product Code
- HKM FDA UDI
- GMDN Term
- Retinoscope, battery-powered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1780 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Retinoscope, battery-powered
ri-scope® retinoscope head slit XL 3.5 V by Rudolf Riester GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Retinoscope, battery-powered.
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- zumax — Zumax Medical Co., LTD · Class I
- zumax — Zumax Medical Co., LTD · Class I
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Cleared under the same submission
K964338 also covers:
- ri-scope® retinoscope head slit XL 3.5 V, — Rudolf Riester GmbH & Co. KG
- ri-vision with retinoscope slit XL 3.5 V, C-handle — Rudolf Riester GmbH & Co. KG
- ri-vision with slit retinoscope XL/LED 3, 5V, C han — Rudolf Riester GmbH & Co. KG
- ri-vision with slit retinoscope XL/LED 3, 5V, C han — Rudolf Riester GmbH & Co. KG
- ri-vision with slit retinoscope XL/LED 3, 5V/120V, — Rudolf Riester GmbH & Co. KG
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
- Rudolf Riester GmbH & Co. KG
Sources (1)
- FDA UDI efbffb87-ba3b-476c-9b49-e78cf2504fac 35 fields · synced May 29, 2026