Protech XL
Catalogue number INOV8-044, listed by Meditech Endoscopy Ltd, United Kingdom, under Endoscopic Storage Cover. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
1510(k) clearance
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Smartdata Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 11 |
Record
| Listed by | Meditech Endoscopy Ltd, United Kingdom |
|---|---|
| FDA product code | OCU |
| Device type | Endoscopic Storage Cover |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Manufacturer |
| 510(k) | K191011 |
| Record published | 2026-01-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| INOV8-044 | 50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endo-Boot | Us Endoscopy | 4 |
| andorate® Universal Endoscope Tip Guard | GA Health Company Limited | 2 |
| ProArmor | Us Endoscopy | 2 |
| Protech L | Meditech Endoscopy Ltd | 1 |
| Protech S | Meditech Endoscopy Ltd | 1 |
| Scope Guard | Gyrus Acmi, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191011 | 2019-05-07 |
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.