Zhejiang Zhonglei Medical Technology Co.Ltd
Active in EUDAMEDChinafrom SRN EUDAMED FDA SRN CN-MF-000039322
- Devices
- 6
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment
- Authorised rep.
- SUNGO Europe B.V.NL
What Zhejiang Zhonglei Medical Technology Co.Ltd makes
Zhejiang Zhonglei Medical Technology Co.Ltd manufactures power wheelchairs designed for mobility assistance, including models such as the N6101 series. These devices are intended for individuals requiring electrically powered mobility solutions, offering adjustable features for user comfort and accessibility.
The company’s power wheelchairs fall under Class II regulatory classification and are listed in the FDA’s 510(k) registry. These devices are regulated under applicable medical device standards in China, where the manufacturer is based.
Catalogue
- Regimes: CE MDR Registry: EUDAMED
- Regimes: CE MDR Registry: EUDAMED
Superight Ref N6101
Regimes: CE MDR Registry: EUDAMEDGUDIDPower wheelchair Ref K242402
Regimes: 510(k) Registry: 510(k)Power wheelchair Ref K242308
Regimes: 510(k) Registry: 510(k)Power wheelchair (N6101) Ref K241686
Regimes: CE MDR 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- CN-MF-000039322
- EUDAMED status
- Active
- EUDAMED registered name
- Zhejiang Zhonglei Medical Technology Co.Ltd
- Registered address
- 1st floor, 2nd floor, No. 66, Dayuan Street, Nanmingshan Street, Liandu District,, 323010, Lishui City, Zhejiang Province, China
- [email protected]
- PRRC contact
- Chengwei Ying
FDA establishments
- Zhejiang Zhonglei Medical Technology Co.Ltd US
Frequently asked questions
How many devices does Zhejiang Zhonglei Medical Technology Co.Ltd have in the registry?
The registry currently lists 6 devices for Zhejiang Zhonglei Medical Technology Co.Ltd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Zhejiang Zhonglei Medical Technology Co.Ltd's devices?
Among its 6 most recently registered devices, Zhejiang Zhonglei Medical Technology Co.Ltd has devices listed in EUDAMED (3 devices), FDA 510(k) (3 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Zhejiang Zhonglei Medical Technology Co.Ltd's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Zhejiang Zhonglei Medical Technology Co.Ltd's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Zhejiang Zhonglei Medical Technology Co.Ltd in the registry?
The most recently registered devices listed for Zhejiang Zhonglei Medical Technology Co.Ltd include Power Wheelchair, Superight and Power wheelchair (N6101).
Which FDA establishments are linked to Zhejiang Zhonglei Medical Technology Co.Ltd?
1 FDA establishment is linked to Zhejiang Zhonglei Medical Technology Co.Ltd in the registry; they are listed on the company page.