Shandong Ande Healthcare Apparatus Co., Ltd.
Registered establishment in Zibo, Shandong, China. 7 device types, 1 clearance.
Shandong Ande Healthcare Apparatus Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Syringe, Piston, Syringe, Antistick and 5 other device types. Its earliest product listing with the FDA dates from 2017.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3012039263 |
| FEI number | 3012039263 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 山东安得医疗用品股份有限公司 |
|---|---|
| Unified social credit code | 91370300746575310A |
| Source | NMPA UDI database |
Location
| City | Zibo |
|---|---|
| Province | Shandong |
| Address | No. 999, Zunxian Road, New & Hi-Tech Zone, |
| Postal code | 255086 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | Class 2 | Disposable IV catheter | 2021 | 12 |
| Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | Class 2 | Closed System Transfer Device | 2023 | 1 |
| Enteral Syringes With Enteral Specific Connectors | Class 2 | Disposable Enteral Syringe | 2020 | 13 |
| Needle, Hypodermic, Single Lumen | Class 2 | Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles, Auto-disable Syringe for Fixed-dose Immunization | 2022 | 71 |
| Set, Administration, Intravascular | Class 2 | Disposable Extension Set, Intravascular administration set AD0101, Intravascular administration set with 0.2micron filter and flow regulator and needlefree Y access port and check valve, Intravascular administration set with flow regulator and needlefree Y access port and check valve AD01, Intravascular administration set with 0.2micron filter AD0301, Intravascular administration set with 1.2micron filter and needlefree Y access port and check valve AD05 and 5 more | 2017 | 49 |
| Syringe, Antistick | Class 2 | Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles, Auto-disable Syringe for Fixed-dose Immunization | 2022 | 39 |
| Syringe, Piston | Class 2 | Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles, Auto-disable Syringe for Fixed-dose Immunization | 2022 | 60 |
Clearances
1 clearance names Shandong Ande Healthcare Apparatus Co., Ltd. as applicant. 6 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K222766 | 2024-04-12 | FPA | Traditional | This company |
| K201460 | 2022-11-23 | ONB | Traditional | Shinva Ande Healthcare Apparatus Co., Ltd. |
| K220057 | 2022-10-07 | MEG | Traditional | Shinva Ande Healthcare Apparatus Co., Ltd. |
| K211484 | 2022-03-01 | MEG | Traditional | Shinva Ande Healthcare Apparatus Co., Ltd. |
| K202060 | 2021-07-23 | FOZ | Traditional | Shinva Ande Healthcare Apparatus Co., Ltd. |
| K193657 | 2020-09-12 | PNR | Traditional | Shinva Ande Healthcare Apparatus Co., Ltd. |
| K162601 | 2017-05-31 | FPA | Traditional | Shinva Ande Healthcare Apparatus Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1988 |
|---|---|
| Main products | Infusion sets, Syringes, IV catheters, Blood collection systems, Disinfection caps |
| Certifications | ISO9001, ISO13485, FDA 510K, CE, MDSAP |
Nearby Manufacturers
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.
The manufacturer named here can complete this record.