Epredia
Cryostar NX50 Cryostat, with low profile blade holder
8manufacturers in China registered for this device type
76catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (4), Shandong (2), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Epredia Laboratory Products Manufacturing (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Shanghai Youding International Trade Co., Ltd. | Shanghai | Shanghai | Repacker / relabeller | 17 |
| Leica Instruments (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 11 |
| Dakewe(Shenzhen) Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 9 |
| RWD Life Science Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
Record
| Listed by | Shandon Diagnostics Limited, United Kingdom |
|---|---|
| FDA product code | IDP |
| Device type | Microtome, Cryostat |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3010 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-02-10 |
| Record revised | 2023-07-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-11-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NX50 CRYOSTAR OPH | In distribution | |
| NX50 CRYOSTAR OPHD | In distribution | |
| HM525 NX CRYOSTAT | In distribution | |
| NX70 CRYOSTAR WITH HOMVP | In distribution | |
| NX70 CRYOSTAR WITH | In distribution | |
| NX70 CRYOSTAR WITH UPBLADE HOLDER | In distribution | |
| NX50 CRYOSTAR OPHD | In distribution | |
| NX50 HOPD, 220-230V | In distribution | |
| NX70 CRYOSTAR WITH UPBLADE HOLDER | In distribution | |
| NX50 CRYOSTAR HOP110-120V | In distribution | |
| HM525 NX system, 110-120V | In distribution | |
| NX50 CRYOSTAR HOVP 110-120V | In distribution | |
| NX50 OPD 100-120V | In distribution | |
| NX50 CRYOSTAR OPHD | In distribution | |
| NX50 OP, 220-230V | In distribution | |
| NX50 CRYOSTAR OPHVD | In distribution | |
| NX50 HOVP, 220-230V | In distribution | |
| NX70 CRYOSTAR WITH UPBLADE HOLDER | In distribution | |
| NX70 CRYOSTAR WITH COLD D | In distribution | |
| NX50 CRYOSTAR HOVPD 110-120V | In distribution | |
| HM525 NX system + UV, 110-120V | In distribution | |
| NX70 CRYOSTAR 220-230V | In distribution | |
| NX50 CRYOSTAR OPDV | In distribution | |
| NX70 CRYOSTAR WITH | In distribution | |
| NX50 CRYOSTAR OPD | In distribution | |
| HM525 NX system+UV, 220-240V, 50HZ | In distribution | |
| NX70 SYSTEM WITH HOMVP, 110-120V | In distribution | |
| NX70 CRYOSTAR WITH | In distribution | |
| NX50 CRYOSTAR OP 100-120V | In distribution | |
| NX70 CRYOSTAR WITH COLD D | In distribution | |
| NX50 CRYOSTAR OVP 100-120V | In distribution | |
| NX70 SYSTEM WITH HOMVPD, 110-120V | In distribution | |
| NX70 CRYOSTAR WITH COLD D | In distribution | |
| HM525 NX UV Cryostat-UK | In distribution | |
| Avantik QS12 Cryostat-UK | In distribution | |
| NX50 CRYOSTAR OPD | In distribution | |
| NX50 OVPD, 220-230V | In distribution | |
| HM525 NX UV CRYOSTAT | In distribution | |
| NX50 CRYOSTAR OP | In distribution | |
| NX50 CRYOSTAR OPHVD | In distribution | |
| NX70 CRYOSTAR WITH COLD D | In distribution | |
| NX70 SYSTEM WITH HOMP, 100V, 50/60HZ | In distribution | |
| NX70 with HOMP, 220-240V | In distribution | |
| NX50 CRYOSTAR OVPD 100-120V | In distribution | |
| NX50 CRYOSTAR OPHVD | In distribution | |
| NX70 CRYOSTAR WITH COLD D | In distribution | |
| NX50 CRYOSTAR OPH | In distribution | |
| NX50 CRYOSTAR HOVP 100V | In distribution | |
| NX50 HOVPD, 220-230V | In distribution | |
| NX50 CRYOSTAR OP 220-230V | In distribution | |
| NX50 CRYOSTAR OPV | In distribution | |
| NX50 CRYOSTAR WITH HEIGHT | In distribution | |
| NX50 CRYOSTAR HOP 100V. | In distribution | |
| NX50 CRYOSTAR OPDV | In distribution | |
| HM525 NX system, 220-240V, 50Hz | In distribution | |
| NX50 CRYOSTAR OPV | In distribution | |
| NX50 HOP, 220-230V | In distribution | |
| NX70 CRYOSTAR 100V | In distribution | |
| NX50 CRYOSTAR OPHV | In distribution | |
| NX70 CRYOSTAR WITH UPBLADE HOLDER | In distribution | |
| NX70 CRYOSTAR 110-120V | In distribution | |
| NX70 with HOMPD, 220-240V | In distribution | |
| NX50 OVP, 220-230V | In distribution | |
| NX50 OPD, 220-230V | In distribution | |
| NX50 CRYOSTAR HOVPD 110V | In distribution | |
| NX50 CRYOSTAR HOPD 110V | In distribution | |
| NX50 CRYOSTAR OPHV | In distribution | |
| HM525 NX Cryostat-UK | In distribution | |
| NX70 CRYOSTAR WITH COLD D | In distribution | |
| NX50 CRYOSTAR OPH | In distribution | |
| HM525 NX CRYOSTAT | In distribution | |
| NX70 CRYOSTAR WITH UPBLADE HOLDER | In distribution | |
| NX50 CRYOSTAR HOPD 110-120V | In distribution | |
| NX70 CRYOSTAR WITH HOMVPD | In distribution | |
| HM525 NX UV CRYOSTAT | In distribution | |
| Avantik QS12 UV Cryostat-UK | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tissue-Tek® Cryo3® | Sakura Finetek U.S.A., Inc. | 7 |
| CT520 Cryostat Microtome | Dakewe(Shenzhen) Medical Equipment Co., Ltd. | 1 |
| 6250 Cryostat Microtome | Dakewe(Shenzhen) Medical Equipment Co., Ltd. | 1 |
| CT620 Cryostat Microtome | Dakewe(Shenzhen) Medical Equipment Co., Ltd. | 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.