Glean
Glean Sensor with Female Insertion Tool 5 Pack
1manufacturer
6catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Linx (Asia) Trading Co., Ltd. | Dongguan | Guangdong | Manufacturer | 1 |
Record
| Listed by | Bright URO, Inc., United States |
|---|---|
| FDA product code | EXQ |
| Device type | Cystometer, Electrical Recording |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1620 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2025-09-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UFM-1000 | In distribution | |
| GUS-1000-M | In distribution | |
| GUS-1000-F | In distribution | |
| GUS-1000-M | In distribution | |
| GUS-1000-F | In distribution | |
| UFM-1000-CP | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Atmos | Bioengineering Laboratories SRL | 4 |
| Atmos | Delta Med SpA | 4 |
| UroFlow Scale | Srs Medical Systems, Inc. | 2 |
| EMG Elect. w/Lead Wire Set, EP (1 set of 3/bag) | Srs Medical Systems, Inc. | 2 |
| Flowsensor3-BT | Medical Measurement Systems B.V. | 2 |
| Solar Blue Module | Medical Measurement Systems B.V. | 1 |
| EasyPro 4.1 Base Unit | Srs Medical Systems, Inc. | 1 |
| UroCuff-DC Disposable, Single | Srs Medical Systems, Inc. | 1 |
| Flowstar NS | Medical Measurement Systems B.V. | 1 |
| Flowstar | Medical Measurement Systems B.V. | 1 |
| Pro Advantage | National Distribution & Contracting Inc | 1 |
| Tri-Electrode Surface EMG | Srs Medical Systems, Inc. | 1 |
Showing 12 of 22. All products under Cystometer, Electrical Recording
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253537 | 2026-04-16 |
| K243052 | 2025-03-24 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.