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ri-scope® de luxe Oto- L3/Ophthalmo. L2, LED 3, 5V/
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- ri-scope® de luxe Oto- L3/Ophthalmo. L2, LED 3,5V/ FDA UDI
- Generic Name
- ENT diagnostic set FDA UDI
- Device Name
- The Riester otoscope is produced for illumination and examination of the auditory canal in combination with Riester ear specula The Riester ophthalmoscope is produced for the examination of the eye and the eyeground. FDA UDI
- Model / Reference
- 3774-203 FDA UDI
- Description
- The Riester otoscope is produced for illumination and examination of the auditory canal in combination with Riester ear specula The Riester ophthalmoscope is produced for the examination of the eye and the eyeground. FDA UDI
Identifiers
- Catalog Number
- 3774-203 FDA UDI
- Primary DI / UDI-DI
- 04045396182639 FDA UDI
- 510(k) Number
- K950913 FDA UDI
- FDA Product Code
- ERA FDA UDI
- GMDN Term
- ENT diagnostic set FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4770 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: ENT diagnostic set
ri-scope® de luxe Oto- L3/Ophthalmo. L2, LED 3, 5V/ by Rudolf Riester GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K950913 also covers:
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
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 3617aa46-179f-4e82-8e99-a1c8883ee789 35 fields · synced May 30, 2026