Leica Biosystems
PEGASUS High Melt Parablocks
5manufacturers in China registered for this device type
14catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Diatrust Medical Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 48 |
| Citotest Labware Manufacturing Co., Ltd. | Haimen | Jiangsu | Repacker / relabeller | 46 |
| Citotest Scientific Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 46 |
| Jiangsu Huida Medical Instruments Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 10 |
| Dakewe(Shenzhen) Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 9 |
Record
| Listed by | Leica Biosystems Richmond, Inc., United States |
|---|---|
| FDA product code | KEO |
| Device type | Formulations, Paraffin, All |
| Device class | Class 1 |
| Regulation | 21 CFR 864.4010 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-12-19 |
| Record revised | 2025-04-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 000000000003801360 | 10 | In distribution | |
| 39V5001 | 4 | In distribution | |
| 39V4001 | 4 | In distribution | |
| 39V1001 | 5 | In distribution | |
| 000000000003801320 | 10 | In distribution | |
| 39V3001 | 5 | In distribution | |
| 000000000003801450 | 4 | In distribution | |
| 000000000003801340 | 10 | In distribution | |
| 000000000039602004 | 8 | In distribution | |
| 000000000039602012 | 4 | In distribution | |
| 000000000003801470 | 10 | In distribution | |
| 000000000039601006 | 8 | In distribution | |
| 000000000039603002 | 8 | In distribution | |
| 000000000039601095 | 8 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epredia | Richard-Allan Scientific LLC | 14 |
| Tissue-Tek Xpress® | Sakura Finetek U.S.A., Inc. | 1 |
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.