Identity
- Trade Name
- econom® XL 3.5 V, 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. The nasal speculum is produced for illumination and therefore examination of the inside of the nose. The blade holder is produced for examination of the oral cavity and pharynx in combination with commercial wooden and plastic blades. The laryngeal mirrors are produced for mirroring or examination of the oral cavity and pharynx in combination with the Riester bent-arm illuminator. FDA UDI
- Model / Reference
- 2052-202 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. The nasal speculum is produced for illumination and therefore examination of the inside of the nose. The blade holder is produced for examination of the oral cavity and pharynx in combination with commercial wooden and plastic blades. The laryngeal mirrors are produced for mirroring or examination of the oral cavity and pharynx in combination with the Riester bent-arm illuminator. FDA UDI
Identifiers
- Catalog Number
- 2052-202 FDA UDI
- Primary DI / UDI-DI
- 04045396130616 FDA UDI
- 510(k) Number
- K925754 FDA UDI
- FDA Product Code
- EPY FDA UDI
- GMDN Term
- ENT diagnostic set FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.1800 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
econom® 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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Cleared under the same submission
K925754 also covers:
- Nasal speculum, chrome plated — Rudolf Riester GmbH & Co. KG
- Reusable ear specula Ø 2 mm, — Rudolf Riester GmbH & Co. KG
- Reusable ear specula Ø 3 mm, — Rudolf Riester GmbH & Co. KG
- Reusable ear specula Ø 4 mm, — Rudolf Riester GmbH & Co. KG
- Reusable ear specula Ø 5 mm, — Rudolf Riester GmbH & Co. KG
- Reusable nasal specula Ø9 mm, — Rudolf Riester GmbH & Co. KG
- econom® Vac. 2.7 V / XL 2.5 V, — Rudolf Riester GmbH & Co. KG
- econom® Vac. 2.7 V / XL 2.5 V, C-handle — Rudolf Riester GmbH & Co. KG
- econom® XL 2.5 V, — Rudolf Riester GmbH & Co. KG
- econom® XL 3.5 V, C-handle, — 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 3287be55-c9a9-4aa9-a3ff-1fdc389dce00 35 fields · synced May 30, 2026