Identity
- Trade Name
- Insighter FDA UDI
- Generic Name
- Flexible video laryngoscope FDA UDI
- Model / Reference
- iS3-F FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970831723154 FDA UDI
- FDA Product Code
- CAL FDA UDI
- GMDN Term
- Flexible video laryngoscope FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5530 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Chlorine Dioxide FDA UDI
Category: Flexible video laryngoscope
Insighter by Shenzhen Insighters Medical Technology Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video laryngoscope.
- PEMF - PHYSIO-STIM — Orthofix US LLC · Class II
- PEMF - PHYSIO-STIM — Orthofix US LLC · Class II
- PEMF - CERVICAL-STIM — Orthofix US LLC · Class II
- PEMF - CERVICAL-STIM — Orthofix US LLC · Class III
- RHINO-LARYNGO VIDEOSCOPE — Olympus Medical Systems Corporation · Class II
- PEMF - PHYSIO-STIM — Orthofix US LLC · Class III
- SourceMark — SOURCEMARK, LLC. · Class I
- PEMF - PHYSIO-STIM — Orthofix US LLC · Class III
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 |
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Manufacturer
- Manufacturer
- Shenzhen Insighters Medical Technology Co., Ltd.
Sources (1)
- FDA UDI bbbd1555-c466-48ba-913a-4e6ec6be6427 32 fields · synced May 30, 2026