Data / Medical devices / China / Shandong Ande Healthcare Apparatus Co., Ltd.
Shandong Ande Healthcare Apparatus Co., Ltd.: FDA-registered device maker in Zibo Shandong, China, 7 510(k) clearances
Shandong Ande Healthcare Apparatus Co., Ltd. is registered with the FDA (registration 3012039263) in Zibo Shandong, China. It lists 7 device types. The FDA files 7 510(k) clearances under its listings, the newest dated April 12, 2024. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3012039263
- Address
- No. 999, Zunxian Road, New & Hi-Tech Zone, Zibo Shandong, China, 255086
- Owner or operator
- Shandong Ande Healthcare Apparatus Co., Ltd. (10056160)
- Roles
- Manufacturer
- First device listed
- November 10, 2017
- Registered through
- 2027
- Brand names listed
- Auto-disable Syringe for Fixed-dose Immunization, Closed System Transfer Device, Disposable Enteral Syringe, Disposable Extension Set, Disposable IV catheter, Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles, Intravascular administration set AD0101, Intravascular administration set with 0.2micron filter AD0301 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Manufacturer | accessdata.fda.gov |
| Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | ONB | 2 | Manufacturer | accessdata.fda.gov |
| Enteral Syringes With Enteral Specific Connectors | PNR | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Antistick | MEG | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 12, 2024 | K222766 | Disposable Extension Set | FPA | Substantially Equivalent | Shandong Ande Healthcare Apparatus Co., Ltd. | accessdata.fda.gov |
| November 23, 2022 | K201460 | Closed System Transfer Device | ONB | Substantially Equivalent | Shinva Ande Healthcare Apparatus Co., Ltd. | accessdata.fda.gov |
| October 7, 2022 | K220057 | Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization | MEG | Substantially Equivalent | Shinva Ande Healthcare Apparatus Co., Ltd. | accessdata.fda.gov |
| March 1, 2022 | K211484 | Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles | MEG | Substantially Equivalent | Shinva Ande Healthcare Apparatus Co., Ltd. | accessdata.fda.gov |
| July 23, 2021 | K202060 | Disposable IV catheter | FOZ | Substantially Equivalent | Shinva Ande Healthcare Apparatus Co., Ltd. | accessdata.fda.gov |
| September 12, 2020 | K193657 | Disposable Enteral Feeding Syringe with Enfit Connector | PNR | Substantially Equivalent | Shinva Ande Healthcare Apparatus Co., Ltd. | accessdata.fda.gov |
| May 31, 2017 | K162601 | Infusion Set for Single Use | FPA | Substantially Equivalent | Shinva Ande Healthcare Apparatus Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Administration, Intravascular
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Syringe, Piston
- All makers of Syringe, Antistick
- All makers of Enteral Syringes With Enteral Specific Connectors
- All makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Updated April 12, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.