Tissue-Tek® Uni-Cassette®
Standard Stacked Cassettes, Orange
16manufacturers in China registered for this device type
50catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Guangdong (4), Fujian (4). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acot Plastics (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 8 |
| HUA Cheng XIN Plastic Mold Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Guangzhou Komaspec Mechanical AND Electrical Products Manufa | Huashan Town, Huadu District | Guangdong | Contract manufacturer | 4 |
| Inplast Plastic & Electronics Co., Ltd. | Suzhou New District | Jiangsu | Contract manufacturer | 2 |
| Zhuhai Strong Precision Manufacturing Co., Ltd. | Jin Wan Dist, Zhu Hai | Guangdong | Contract manufacturer | 1 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| 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 |
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Trummed Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 25 |
Showing 12 of 16. All 16 manufacturers in China registered for Cassettes, Tissue
Record
| Listed by | Sakura Finetek U.S.A., Inc., United States |
|---|---|
| FDA product code | IDZ |
| Device type | Cassettes, Tissue |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3010 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-12-18 |
| Record revised | 2023-11-03 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 4155-01 | 2 | In distribution | |
| 8118 | In distribution | ||
| 4118-02 | 2 | In distribution | |
| 8117 | In distribution | ||
| 8180 | In distribution | ||
| 4135-01 | 2 | In distribution | |
| 4170-02 | 6 | In distribution | |
| 4118-01 | 2 | In distribution | |
| 4045 | 2 | In distribution | |
| 8087 | In distribution | ||
| 8088 | In distribution | ||
| 4135-02 | 2 | In distribution | |
| 8086 | In distribution | ||
| 4180-02 | 2 | In distribution | |
| 4120-02 | 2 | In distribution | |
| 8119 | In distribution | ||
| 4153-01 | 2 | In distribution | |
| 4170-01 | 6 | In distribution | |
| 4172 | 2 | In distribution | |
| 4087 | 2 | In distribution | |
| 8156 | In distribution | ||
| 4157-01 | 2 | In distribution | |
| 4180-01 | 2 | In distribution | |
| 4117-02 | 2 | In distribution | |
| 4157-02 | 2 | In distribution | |
| 8045 | In distribution | ||
| 8155 | In distribution | ||
| 8154 | In distribution | ||
| 8170 | In distribution | ||
| 4119-01 | 2 | In distribution | |
| 4120-01 | 2 | In distribution | |
| 8157 | In distribution | ||
| 4154-02 | 2 | In distribution | |
| 4119-02 | 2 | In distribution | |
| 4154-01 | 2 | In distribution | |
| 8120 | In distribution | ||
| 8174 | In distribution | ||
| 4174 | 2 | In distribution | |
| 8090 | In distribution | ||
| 4086 | 2 | In distribution | |
| 8172 | In distribution | ||
| 4090 | 2 | In distribution | |
| 8135 | In distribution | ||
| 4156-01 | 2 | In distribution | |
| 4156-02 | 2 | In distribution | |
| 4153-02 | 2 | In distribution | |
| 4117-01 | 2 | In distribution | |
| 4088 | 2 | In distribution | |
| 8153 | In distribution | ||
| 4155-02 | 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Embedding Cassette | Typenex Medical, LLC | 532 |
| Epredia | Richard-Allan Scientific LLC | 348 |
| Leica Biosystems | Leica Biosystems Richmond, Inc. | 263 |
| Fisherbrand | Fisher Scientific Company L.L.C. | 137 |
| Tissue-Tek® Paraform® | Sakura Finetek U.S.A., Inc. | 48 |
| Histo-Tek® | Sakura Finetek U.S.A., Inc. | 36 |
| Globe Scientific | Globe Scientific, LLC | 29 |
| Tissue-Tek® | Sakura Finetek U.S.A., Inc. | 23 |
| N/A (Approved Vendor) | Grainger International, Inc. | 15 |
| Cassette Stainless Steel Base Mold | Typenex Medical, LLC | 10 |
| Disposable Base Mold | Typenex Medical, LLC | 6 |
| Tissue-Tek® Mega-Cassette | Sakura Finetek U.S.A., Inc. | 2 |
Showing 12 of 24. All products under Cassettes, Tissue
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.