Zhejiang Kindly Medical Devices Co., Ltd.
Manufacturer and brand owner in Wenzhou, Zhejiang, China. 16 device types, 1 product catalogued, 5 clearances.
Zhejiang Kindly Medical Devices Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Syringe, Piston, Adaptor, Catheter and 14 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2008.
16device types registered with the FDA
1product
5510(k) clearances
6recalls
Registration
| Registered name | ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 9615588 |
| FEI number | 3003560965 |
| DUNS | 420815086 |
| Establishment type | Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 浙江康德莱医疗器械股份有限公司 |
|---|---|
| Source | export sales certificate, Zhejiang medical products administration |
Location
| City | Wenzhou |
|---|---|
| Province | Zhejiang |
| Address | No.758, 5th Binhai Road Binhai Industrial Park, Longwan |
| Postal code | 325025 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Adaptor, Catheter | Class 1 | Red End Cap Male/Female, Blue End Cap Male/Female | 2019 | 4 |
| Adaptor, Holder, Syringe | Class 1 | EXEL Multi-Sample Luer Holder | 2024 | 15 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | Class 2 | 2016 | 12 | |
| Low Dead Space Needle, Single Lumen, Hypodermic | Class 2 | LDS Needle, OcuSafe® Needle, Needle, VitreJect® Safety Needle, SteriCap® Safety Needle, OcuSafe® Ophthalmic Needle and 1 more | 2026 | 2 |
| Low Dead Space Piston Syringe | Class 2 | VitreJect® Ophthalmic Syringes, VitreJect® Syringes, Luer Lock Syringe with Safety Needle | 2024 | 5 |
| Needle, Aspiration And Injection, Disposable | Class 1 | Sol-M Blunt Fill Needle with and without Filter 18Gx1-1/2”, Blunt Fill Needle with/without Filter, Mckesson Blunt Fill Needle, Blunt Needles with and without Filter, Special blunted needle | 2018 | 37 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | Class 2 | Quincke Spinal Needle, Spinal Needle, Anesthesia needles, Spinal Anesthesia Needles, Tuohy Needle | 2019 | 9 |
| Needle, Hypodermic, Single Lumen | Class 2 | Sterile Hypodermic Needles for Single Use, LDS Needle, OcuSafe® Needle, Needle, VitreJect® Safety Needle, SteriCap® Safety Needle and 17 more | 2014 | 71 |
| Ophthalmic Needle | Class 2 | LDS Needle, OcuSafe® Needle, Needle, VitreJect® Safety Needle, SteriCap® Safety Needle, OcuSafe® Ophthalmic Needle and 1 more | 2026 | 2 |
| Ophthalmic Syringe | Class 2 | VitreJect® Ophthalmic Syringes, VitreJect® Syringes | 2024 | 3 |
| Parenteral Administration Kit | Class 2 | Insulin Kits | 2025 | 5 |
| Set, Administration, Intravascular | Class 2 | Push Button SafetyBlood Collection Set, EXEL Scalp Vein Set | 2012 | 49 |
| Syringe, Antistick | Class 2 | EXEL Disposable Hypodermic Needle, Luer Lock Syringe with Safety Needle, Luer Lock Syringe with Exchangeable Needle | 2025 | 39 |
| Syringe, Piston | Class 2 | VitreJect® Ophthalmic Syringes, VitreJect® Syringes, EXEL Disposable Hypodermic Needle, Disposable Hypodermic Needle, Luer Lock Syringe with Safety Needle, Luer Lock Syringe with Exchangeable Needle and 2 more | 2008 | 60 |
| System, Blood Collection, Vacuum-Assisted, Manual | Class 1 | Blood Collection Tube Holder, Blood Transfer Device, Blood Collection Device, Blood Culture Device, Blood Culture Device Male Luer Lock, Blood Culture Device Female Luer Lock and 16 more | 2012 | 31 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | Class 2 | Blood collection set, Safety blood collection set, Blood Collection and Infusion Set, Push Button SafetyBlood Collection Set, Blood collecting needle with Holder, Safety Blood Collection Needle and 20 more | 2018 | 23 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Ezfine Thin Wall Hypodermic Needle | FMI | 1 |
Clearances
5 clearances name Zhejiang Kindly Medical Devices Co., Ltd. as applicant. 1 is 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 |
|---|---|---|---|---|
| K223334 | 2022-12-16 | FMI | Traditional | This company |
| K213183 | 2022-10-14 | FMI | Traditional | This company |
| K181069 | 2018-08-28 | FMI | Traditional | This company |
| K172763 | 2018-06-04 | JKA | Traditional | This company |
| K171518 | 2018-01-05 | BSP | Traditional | This company |
| K233037 | 2023-12-12 | FMI | Traditional | Zhejiang Kindly Medical Device Co., Ltd. |
Recalls
6 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Closed |
|---|---|---|---|---|
| 2021-08-24 | Class II | Nonconforming Material/Component | Potential for difficulty in safety mechanism activation. | 2023-07-21 |
| 2021-08-24 | Class II | Nonconforming Material/Component | Potential for difficulty in safety mechanism activation. | 2023-07-21 |
| 2021-08-24 | Class II | Nonconforming Material/Component | Potential for difficulty in safety mechanism activation. | 2023-07-21 |
| 2021-08-24 | Class II | Nonconforming Material/Component | Potential for difficulty in safety mechanism activation. | 2023-07-21 |
| 2021-08-24 | Class II | Nonconforming Material/Component | Potential for difficulty in safety mechanism activation. | 2023-07-21 |
| 2021-08-24 | Class II | Nonconforming Material/Component | Potential for difficulty in safety mechanism activation. | 2023-07-21 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1987 |
|---|---|
| Factory area | 36,072 ㎡ |
| Main products | Disposable blood collection needles, Sterile IV catheters, Insulin pen needles, Biopsy needles, Dental injection needles |
| Certifications | National High-Tech Enterprise, Zhejiang Province Enterprise Technology Center, CNAS National Laboratory Accreditation (2023), ILAC International Mutual Recognition Accreditation (2023) |
| Export markets | America, Europe, South America, Africa, Middle East, Southeast Asia |
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.