Catalogue number 52080, listed by Coloplast A/S, Denmark, under Cannula, Manipulator/Injector, Uterine. 5 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Guangdong (2), Zhejiang (2), Beijing (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Meridian VPS | Listed by | Coloplast A/S, Denmark |
| FDA product code | LKF |
| Device type | Cannula, Manipulator/Injector, Uterine |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K173501 |
| Record published | 2023-09-22 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize. |
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.