Wenzhou Caretek Medical Device Co., Ltd.
Manufacturer and brand owner in Wenzhou, Zhejiang, China. 30 device types, 9 products catalogued.
Wenzhou Caretek Medical Device Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Otoscope, Percussor and 28 other device types. 9 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2009.
Registration
| Registered name | WENZHOU CARETEK MEDICAL DEVICE CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3007703436 |
| FEI number | 3007703436 |
| DUNS | 527815967 |
| Establishment type | Contract manufacturer, Private-label distributor, Manufacturer, Exporter |
Location
| City | Wenzhou |
|---|---|
| Province | Zhejiang |
| Address | Room 1301.Yue Shang Mansion.Nanhui.Lucheng. |
| Postal code | 325000 |
| Country | China |
What It Makes
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| E+R,Ever Ready First Aid | LDE | 9 |
| Dixieems | LDE | 8 |
| Dixieems | DXQ | 6 |
| E+R | LDE | 3 |
| PediaPals | FZY | 2 |
| ASA | DXQ | 2 |
| Ever Ready First Aid | LDE | 1 |
| Pedia Pals | DXQ | 1 |
| Yalomi | FLL | 1 |
Clearances
No clearance names Wenzhou Caretek Medical Device Co., Ltd. as applicant. 15 are held by other companies 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 |
|---|---|---|---|---|
| K230889 | 2024-04-03 | FLL | Traditional | Wenzhou Yosun Medical Technology Co., Ltd. |
| K231478 | 2023-12-15 | DXN | Traditional | Wenzhou Yosun Medical Technology Co., Ltd. |
| K230859 | 2023-06-28 | DXQ | Traditional | Wenzhou Kangshun Medical Devices Co., Ltd. |
| K201843 | 2020-10-23 | FLL | Traditional | Wenzhou Yosun Medical Technology Co., Ltd. |
| K180984 | 2019-01-03 | MMK | Traditional | Ningbo Maxcon Medical Technology Co., Ltd. |
| K180207 | 2018-11-28 | FLL | Traditional | Alicn Medical Shenzhen, Inc |
| K182652 | 2018-11-20 | FLL | Traditional | Kangfu Medical Equipment Factory |
| K160999 | 2016-08-01 | FLL | Traditional | Hangzhou Hua’an Medical & Health Instruments Co., |
| K102718 | 2010-12-13 | FLL | Traditional | International Regulatory Consultants, LLC (Irc) |
| K090014 | 2009-04-09 | DXQ | Traditional | Caremate Medical Device Co., Ltd. |
| K083043 | 2008-10-27 | DXN | Traditional | Shenzhen Kingyield Technology Co., Ltd. |
| K082042 | 2008-09-03 | MMK | Traditional | Zhejiang Gongdong Medical Plastic Factory |
| K041694 | 2004-09-13 | FLL | Traditional | Hangzhou Hua’an Medical & Health Instruments Co., |
| K951041 | 1995-10-31 | DXQ | Traditional | Pedia Pals, Inc. |
| K951040 | 1995-10-31 | DXQ | Traditional | Pedia Pals, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2005 |
|---|---|
| Main products | Blood pressure monitors, Thermometers, Stethoscopes, Clinical diagnostic tools |
| Export markets | Worldwide |
| OEM and ODM | Offered |
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.