Identity
- Trade Name
- Single-Use Rhinolaryngoscope FDA UDI
- Generic Name
- Flexible video otorhinolaryngoscope, single-use FDA UDI
- Model / Reference
- RH-M32A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970462546481 FDA UDI
- 510(k) Number
- K232435 FDA UDI
- FDA Product Code
- EOB FDA UDI
- GMDN Term
- Flexible video otorhinolaryngoscope, single-use 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Flexible video otorhinolaryngoscope, single-use
Single-Use Rhinolaryngoscope by Shenzhen HugeMed Medical Technical Development Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Flexible video otorhinolaryngoscope, single-use.
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- Single-Use Flexible Rhinolaryngoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
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- Single-Use Flexible Rhinolaryngoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
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- aScope™ 4 RhinoLaryngo Intervention — Ambu A/S · Class II
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
Sources (1)
- FDA UDI 3818b49f-3486-4fa4-8783-16ee95427e8a 33 fields · synced May 30, 2026