Shenzhen Xpectvision Technology Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 4 device types, 4 products catalogued, 2 clearances.
Shenzhen Xpectvision Technology Co., Ltd. is a repacker / relabeller holding a current FDA establishment registration. The registration covers Holder, Film, X-Ray, Unit, X-Ray, Extraoral With Timer and 2 other device types. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2022.
Registration
| Registered name | SHENZHEN XPECTVISION TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3022107311 |
| FEI number | 3022107311 |
| DUNS | 560445687 |
| Establishment type | Repacker / relabeller, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 深圳帧观德芯科技有限公司 |
|---|---|
| Unified social credit code | 91440300329532213L |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 1st Floor, Building A31, No.44 Xiangrui 3rd Road |
| Postal code | 518000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Chair, Dental, Without Operative Unit | Class 1 | Sensor sheath, Model XVC001, XVC002, XVC003, XVC004 | 2022 | 38 |
| Holder, Film, X-Ray | Class 1 | Intraoral X-ray Sensor Holder, Model XVH001 | 2022 | 40 |
| System, X-Ray, Extraoral Source, Digital | Class 2 | XVD2530, XVD2121 Plus | 2022 | 10 |
| Unit, X-Ray, Extraoral With Timer | Class 2 | XpectVision, Handheld Dental X-ray System, XVbeam2000 | 2024 | 8 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| XLinearVision | MUH | 2 |
| XLinearVision | NRU | 1 |
| XpectVision | EHD | 1 |
| XLinearVision | EGZ | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K233914 | 2024-02-08 | EHD | Traditional | This company |
| K220277 | 2022-02-17 | MUH | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2015 |
|---|---|
| Main products | Photon-counting X-ray detectors, Intraoral sensors, Handheld X-ray machines, Intraoral scanners |
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.