Shenzhen Envisen Industry Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 1 device type, 1 product catalogued, 2 clearances.
Shenzhen Envisen Industry Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Support, Patient Position. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2018.
1device type
1product
2510(k) clearances
Registration
| Registered name | SHENZHEN ENVISEN INDUSTRY CO. LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3007773209 |
| FEI number | 3007773209 |
| DUNS | 529112578 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 深圳安维森实业有限公司 |
|---|---|
| Unified social credit code | 91440300752517264R |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Block 1, 40 Jianlong Street |
| Postal code | 518115 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Support, Patient Position | Class 1 | QView | 2018 | 66 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Qview | CCX | 3 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K212945 | 2022-03-01 | FLL | Traditional | This company |
| K103584 | 2011-06-10 | DQA | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2003 |
|---|---|
| Main products | SpO2 sensors, Bilumen breathing circuits (QTube), Temperature probes, NIBP cuffs, Medical cables |
| Certifications | ISO 13485, ISO 9001:2000, ISO 14000, TUV Rheinland Product Safety certification |
| Export markets | International markets |
| 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.