Is this your brand? Sign in to claim ownership.
Sign in to claim this brandWenzhou Caretek Medical Device Co., Ltd.
US
Last updated May 27, 2026
What Wenzhou Caretek Medical Device Co., Ltd. makes
Wenzhou Caretek Medical Device Co., Ltd. manufactures mechanical external stethoscopes, aneroid manual sphygmomanometers, reusable percussion hammers, and infrared skin thermometers for patient temperature measurement. Their product line includes first aid kits, pediatric stethoscopes, and reusable diagnostic tools designed for clinical and home use.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the US.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Wenzhou Caretek Medical Device Co., Ltd. manufacture?
Wenzhou Caretek Medical Device Co., Ltd. specializes in mechanical external stethoscopes, aneroid manual sphygmomanometers (blood pressure monitors), reusable percussion hammers, and infrared skin thermometers. These devices are designed for clinical and home use, including first aid kits and pediatric-specific tools like the PediaPals stethoscope. Their product line focuses on manual, reusable diagnostic instruments.
Where is Wenzhou Caretek Medical Device Co., Ltd. based?
The company operates from the United States. While its name suggests a Chinese origin, its manufacturing and regulatory presence are established in the US market, where its devices are listed and tracked.
Which regulatory registries list Wenzhou Caretek Medical Device Co., Ltd.’s devices?
The company’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry tracks Class I and Class II devices, ensuring traceability and compliance with US regulatory requirements. The UDI system helps healthcare providers and authorities verify device details.
How are Wenzhou Caretek Medical Device Co., Ltd.’s devices classified under FDA regulations?
The manufacturer’s devices fall into FDA’s Class I and Class II categories. Class I devices are generally low-risk (e.g., reusable percussion hammers), while Class II devices carry moderate risk and require stricter controls (e.g., some stethoscopes or thermometers). Classification depends on factors like intended use, potential harm, and design complexity.
Why do some of Wenzhou Caretek’s devices appear multiple times in the example list?
The repeated device names (e.g., *E+R Ever Ready First Aid* or *DIXIEEMS*) likely represent variations of the same product line, such as different models, packaging, or minor design iterations. These duplicates reflect the company’s focus on modular or multi-purpose kits (e.g., first aid sets combining multiple tools) rather than entirely distinct devices.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 527815967
Catalogue (33)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| E+R, Ever Ready First Aid | 143214 | FDA UDI | Class I | Active |
| Dixieems | 422602O | FDA UDI | Class I | Active |
| PediaPals | 100008 | FDA UDI | Class I | Active |
| Dixieems | ZHE920PK | FDA UDI | Class II | Active |
| E+R, Ever Ready First Aid | 143223 | FDA UDI | Class I | Active |
| Dixieems | 249901PK | FDA UDI | Class II | Active |
| Dixieems | 422602R | FDA UDI | Class I | Active |
| Dixieems | 143114 | FDA UDI | Class I | Active |
| E+r | 143231 | FDA UDI | Class I | Active |
| E+r | 143212 | FDA UDI | Class I | Active |
| Dixieems | 422602BKG | FDA UDI | Class I | Active |
| Pedia Pals | 100048 | FDA UDI | Class II | Active |
| Ever Ready First Aid | 422602TB | FDA UDI | Class I | Active |
| Asa | AS-MC-SR-KIT | FDA UDI | Class II | Active |
| E+R, Ever Ready First Aid | 143205 | FDA UDI | Class I | Active |
| Dixieems | 422208O | FDA UDI | Class II | Active |
| Yalomi | Y-IRT360 | FDA UDI | Class II | Active |
| E+r | 143226 | FDA UDI | Class I | Active |
| Dixieems | 422602YG | FDA UDI | Class I | Active |
| E+R, Ever Ready First Aid | 143126 | FDA UDI | Class I | Active |
| E+R, Ever Ready First Aid | 143200 | FDA UDI | Class I | Active |
| Dixieems | 143105 | FDA UDI | Class I | Active |
| Dixieems | 422602 | FDA UDI | Class I | Active |
| E+R, Ever Ready First Aid | 143201 | FDA UDI | Class I | Active |
| PediaPals | 100009 | FDA UDI | Class I | Active |
| Dixieems | 249901BK | FDA UDI | Class II | Active |
| E+R, Ever Ready First Aid | 143210 | FDA UDI | Class I | Active |
| Dixieems | 249901RB | FDA UDI | Class II | Active |
| E+R, Ever Ready First Aid | 143300B | FDA UDI | Class I | Active |
| Dixieems | 143100 | FDA UDI | Class I | Active |
| Dixieems | ZHE920PUR | FDA UDI | Class II | Active |
| Asa | AS-MC | FDA UDI | Class II | Active |
| E+R, Ever Ready First Aid | 143104 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.