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Zsquare ENT-Flex SINGLE-USE RHINOLARYNGOSCOPE
FDA UDIClass II (US FDA UDI)
by Zsquare Ltd
Identity
- Trade Name
- Zsquare ENT-Flex SINGLE-USE RHINOLARYNGOSCOPE FDA UDI
- Generic Name
- Flexible video otorhinolaryngoscope, single-use FDA UDI
- Device Name
- Zsquare ENT-Flex Single-Use Shell. A single-use flexilble rhinolaryngoscope sterile from package. To be used with Zsquare ENT-Flex Imaging Core and Zsquare ENT-Flex Console. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Zsquare ENT-Flex Single-Use Shell. A single-use flexilble rhinolaryngoscope sterile from package. To be used with Zsquare ENT-Flex Imaging Core and Zsquare ENT-Flex Console. FDA UDI
Identifiers
- Catalog Number
- 200000 FDA UDI
- Primary DI / UDI-DI
- 07290019505006 FDA UDI
- 510(k) Number
- K220004 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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Flexible video otorhinolaryngoscope, single-use
Zsquare ENT-Flex SINGLE-USE RHINOLARYNGOSCOPE by Zsquare Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video otorhinolaryngoscope, single-use.
- Single-Use Flexible Rhinolaryngoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- Single-Use Flexible Rhinolaryngoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- Single-Use Flexible Rhinolaryngoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- aScope™ 4 RhinoLaryngo Slim — Ambu A/S · Class II
- Single-Use Flexible Rhinolaryngoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- aScope™ 4 RhinoLaryngo Slim — Ambu A/S · Class II
- Single-Use Rhinolaryngoscope — Shenzhen HugeMed Medical Technical Development Co., Ltd. · Class II
- Single-Use Flexible Rhinolaryngoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
Cleared under the same submission
K220004 also covers:
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
- Zsquare Ltd
Sources (1)
- FDA UDI 1c1aebcc-ab88-4171-a0ea-5a409d646b4d 36 fields · synced Jun 8, 2026