Identity
- Trade Name
- Reusable ear specula Ø 3 mm, FDA UDI
- Generic Name
- Ear speculum, reusable FDA UDI
- Device Name
- With the Riester ear specula in combination with a Riester otoscope, the auditory canal is illuminated and examined. FDA UDI
- Model / Reference
- 10461 FDA UDI
- Description
- With the Riester ear specula in combination with a Riester otoscope, the auditory canal is illuminated and examined. FDA UDI
Identifiers
- Catalog Number
- 10461 FDA UDI
- Primary DI / UDI-DI
- 04045396010369 FDA UDI
- 510(k) Number
- K925754 FDA UDI
- FDA Product Code
- EPY FDA UDI
- GMDN Term
- Ear speculum, reusable 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: Ear speculum, reusable
Reusable ear specula Ø 3 mm, by Rudolf Riester GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ear speculum, reusable.
- Sklar — Sklar Corporation · Class I
- Sklar® — Sklar Corporation · Class I
- BEAR — Bear-Ent, LLC · Class I
- V. Mueller — STERIS CORPORATION · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- PILLING — TELEFLEX INCORPORATED · Class I
- FENTEX — FENTEX medical GmbH · Class I
- MSI Precision Specialty Instruments — Med Saver, 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 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, — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Rudolf Riester GmbH & Co. KG
Sources (1)
- FDA UDI 3d6246d2-c7a0-42e4-b981-9c222d903137 35 fields · synced Jun 1, 2026