Tissue-Tek®
Waste Collection Bags
6manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (3), Shanghai (2), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Leica Instruments (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 11 |
| Epredia Laboratory Products Manufacturing (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
| Dakewe(Shenzhen) Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 9 |
| RWD Life Science Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
Record
| Listed by | Sakura Finetek U.S.A., Inc., United States |
|---|---|
| FDA product code | IDO |
| Device type | Microtome, Rotary |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3010 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-02-06 |
| Record revised | 2020-12-04 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 4650 | 4 | In distribution | |
| 4658 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epredia | Shandon Diagnostics Limited | 20 |
| Accu-Cut® SRM™ 200 | Sakura Finetek U.S.A., Inc. | 5 |
| Clarapath™ SectionStar™ | Clarapath, Inc. | 2 |
| Accu-Cut® SRM™ 300 LT | Sakura Finetek U.S.A., Inc. | 2 |
| SectionStar | Clarapath, Inc. | 1 |
| 2065A Auto Microtome | Dakewe(Shenzhen) Medical Equipment Co., Ltd. | 1 |
| LS-2065 Rotary Microtome | Dakewe(Shenzhen) Medical Equipment Co., Ltd. | 1 |
| MT1 Rotary Microtome | Dakewe(Shenzhen) Medical Equipment Co., Ltd. | 1 |
| Tissue-Tek AutoSection® | 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.