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EliteVue oto/ophthal. set, LED, 3.5V, with 2C-handles
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- EliteVue oto/ophthal. set,LED,3.5V,with 2C-handles 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
- 2212-203.002 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
- 2212-203.002 FDA UDI
- Primary DI / UDI-DI
- 04045396213753 FDA UDI
- 510(k) Number
- K932506 FDA UDI
- FDA Product Code
- ERA FDA UDI
- GMDN Term
- Ophthalmic/otologic 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: Ophthalmic/otologic diagnostic set
EliteVue oto/ophthal. set, LED, 3.5V, with 2C-handles 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 Ophthalmic/otologic diagnostic set.
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Cleared under the same submission
K932506 also covers:
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — 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 2a8ba729-9b03-4128-9870-2990772bf423 35 fields · synced Jun 1, 2026