Identity
- Trade Name
- COMPACT TOUCH STS FDA UDI
- Generic Name
- Ophthalmic ultrasound imaging system FDA UDI
- Device Name
- Ophthalmic Ultrasound Biomicroscope UBM and automatic STS measurement for ICL sizing The QUANTEL MEDICAL Compact Touch STS UBMTM Ophthalmic Ultrasound System (and its associated Linear 50 MHz probe) is intended to be used for diagnostic imaging and measurement of the eye including: • Visualization of the interior of the eye by B scans. • Make measurements inside the eye (Sulcus to Sulcus, Irido Cornea Angle Left, Irido Cornea Angle Right, Lens curvature and Anterior Chamber depth). FDA UDI
- Model / Reference
- COMPACT TOUCH STS UBM FDA UDI
- Description
- Ophthalmic Ultrasound Biomicroscope UBM and automatic STS measurement for ICL sizing The QUANTEL MEDICAL Compact Touch STS UBMTM Ophthalmic Ultrasound System (and its associated Linear 50 MHz probe) is intended to be used for diagnostic imaging and measurement of the eye including: • Visualization of the interior of the eye by B scans. • Make measurements inside the eye (Sulcus to Sulcus, Irido Cornea Angle Left, Irido Cornea Angle Right, Lens curvature and Anterior Chamber depth). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700542625026 FDA UDI
- FDA Product Code
- IYO FDA UDIITX FDA UDI
- GMDN Term
- Ophthalmic ultrasound imaging system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 FDA UDI892.1570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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Combination Product
No
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HCT/P
No
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Premarket Exempt
No
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Lot / Batch Number
No
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Serial Number
Yes
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Expiration Date
No
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Manufacturing Date
No
FDA UDI
Category: Ophthalmic ultrasound imaging system
Compact Touch Sts by Quantel Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic ultrasound imaging system.
- A-scan probe — Nidek, Inc. · Class II
- ArcScan Insight 100 — Arcscan, Inc. · Class II
- Ultrasonic A/B Scanner for Ophthalmology — Meda , Ltd. · Class II
- Eli Ezer — U.S. OPHTHALMIC, L.L.C. · Class II
- Ellex — ELLEX MEDICAL PTY LTD · Class II
- LIGHTSonic B UBM — Light-Med(Usa), Inc. · Class II
- Ophthalmic Ultrasound Examination Instrument — CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO., LTD · Class II
- B-scan Plus- VET — ACCUTOME, INC. · 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
- Manufacturer
- Quantel Medical
Sources (1)
- FDA UDI cec73d31-2795-47bf-8f81-4d42452824ad 34 fields · synced Jun 6, 2026