Identity
- Trade Name
- Nasopharyngoscope, Flexible FDA UDI
- Generic Name
- Flexible fibreoptic nasopharyngoscope FDA UDI
- Device Name
- Flexible Nasopharyngoscope FDA UDI
- Model / Reference
- R00 FDA UDI
- Description
- Flexible Nasopharyngoscope FDA UDI
Identifiers
- Catalog Number
- FE102 FDA UDI
- Primary DI / UDI-DI
- B366FE102R000 FDA UDI
- 510(k) Number
- K030572 FDA UDI
- FDA Product Code
- EOB FDA UDI
- GMDN Term
- Flexible fibreoptic nasopharyngoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4760 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Flexible fibreoptic nasopharyngoscope
Nasopharyngoscope, Flexible by Ecleris — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible fibreoptic nasopharyngoscope.
- ENTity SDXL Nasopharyngoscope — OPTIM LLC · Class II
- InstaClear — Gyrus Acmi, Inc. · Class II
- BR Surgical, LLC — BR SURGICAL LLC · Class II
- ENT 3.6FP30 Nasopharyngoscope — OPTIM LLC · Class II
- MACHIDA — MACHIDA ENDOSCOPE CO., LTD. · Class II
- ENTity XL (PA Compatible) Nasopharyngoscope — OPTIM LLC · Class II
- InstaClear — Gyrus Acmi, Inc. · Class II
- Entity SDXL Plus Nasopharyngoscope — OPTIM LLC · Class II
Cleared under the same submission
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ecleris
Sources (1)
- FDA UDI b0ca4cf1-3b9c-4d18-9fc7-9d4c685a3f18 37 fields · synced May 30, 2026