Identity
- Trade Name
- econom® Vac. 2.7 V / XL 2.5 V, C-handle FDA UDI
- Generic Name
- ENT diagnostic set FDA UDI
- Device Name
- The Riester otoscope has been produced with examination of the auditory canal in mind, combined with a Riester ear speculum. The Riester ophthalmoscope has been designed for the examination of the eye and its background. FDA UDI
- Model / Reference
- 2050 FDA UDI
- Description
- The Riester otoscope has been produced with examination of the auditory canal in mind, combined with a Riester ear speculum. The Riester ophthalmoscope has been designed for the examination of the eye and its background. FDA UDI
Identifiers
- Catalog Number
- 2050 FDA UDI
- Primary DI / UDI-DI
- 04045396002760 FDA UDI
- 510(k) Number
- K925754 FDA UDI
- FDA Product Code
- HLJ FDA UDI
- GMDN Term
- ENT 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: ENT diagnostic set
econom® Vac. 2.7 V / XL 2.5 V, C-handle by Rudolf Riester GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as ENT diagnostic set.
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- NAR — NORTH AMERICAN RESCUE, LLC. · Class I
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- ENT POCKET LIGHT — C F M TECHNOLOGIES INC · Class I
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® XL 2.5 V, — Rudolf Riester GmbH & Co. KG
- econom® XL 3.5 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 II | Pending data |
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Manufacturer
- Manufacturer
- Rudolf Riester GmbH & Co. KG
Sources (1)
- FDA UDI d01d4244-6964-454e-9517-e8b2df4d0c6e 35 fields · synced Jun 8, 2026