Identity
- Trade Name
- e-scope®otoscope,direct illum./ophthalmoscope XL FDA UDI
- Generic Name
- Ophthalmic/otologic 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
- 2131-200 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
- 2131-200 FDA UDI
- Primary DI / UDI-DI
- 04045396177048 FDA UDI
- 510(k) Number
- K932503 FDA UDI
- FDA Product Code
- HLJ FDA UDI
- GMDN Term
- Ophthalmic/otologic diagnostic set 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: Ophthalmic/otologic diagnostic set
e-scope®otoscope, direct illum./ophthalmoscope XL 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 8fcbbec3-f8db-4add-ae5e-022b4af3e546 35 fields · synced May 30, 2026