Identity
- Trade Name
- pen-scope ophthalmoscope XL 2,5 V FDA UDI
- Generic Name
- Direct ophthalmoscope FDA UDI
- Device Name
- The Riester ophthalmoscope has been designed for the examination of the eye and its background. FDA UDI
- Model / Reference
- 2078 FDA UDI
- Description
- The Riester ophthalmoscope has been designed for the examination of the eye and its background. FDA UDI
Identifiers
- Catalog Number
- 2078 FDA UDI
- Primary DI / UDI-DI
- 04045396002913 FDA UDI
- 510(k) Number
- K932503 FDA UDI
- FDA Product Code
- HLJ FDA UDI
- GMDN Term
- Direct ophthalmoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1570 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: Direct ophthalmoscope
pen-scope ophthalmoscope XL 2, 5 V by Rudolf Riester GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K932503 also covers:
- Pack of 10 pcs. reusable ear specula Ø 2.0 mm, bla — Rudolf Riester GmbH & Co. KG
- Pack of 10 pcs. reusable ear specula Ø 2.5 mm, bla — Rudolf Riester GmbH & Co. KG
- Pack of 10 pcs. reusable ear specula Ø 3.0 mm, — Rudolf Riester GmbH & Co. KG
- Pack of 10 pcs. reusable ear specula Ø 3.0 mm, bla — Rudolf Riester GmbH & Co. KG
- Pack of 10 pcs. reusable ear specula Ø 4.0 mm, bla — Rudolf Riester GmbH & Co. KG
- Pack of 10 pcs. reusable ear specula Ø 5.0 mm, bla — Rudolf Riester GmbH & Co. KG
- Pack of 1000 pcs. reusable ear specula Ø 4.0 mm, — Rudolf Riester GmbH & Co. KG
- e-scope® F.O. otoscope / ophthalmoscope LED 3.7 V, — Rudolf Riester GmbH & Co. KG
- e-scope® F.O. otoscope / ophthalmoscope LED 3.7 V, — Rudolf Riester GmbH & Co. KG
- e-scope® F.O. otoscope / ophthalmoscope XL 2.5 V, — Rudolf Riester GmbH & Co. KG
- e-scope® F.O. otoscope / ophthalmoscope XL 2.5 V, — Rudolf Riester GmbH & Co. KG
- e-scope® F.O. otoscope LED 3.7 V, black, — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Rudolf Riester GmbH & Co. KG
Sources (1)
- FDA UDI 017ac181-f0fa-4000-9864-cf7be4bebc27 35 fields · synced May 30, 2026