Pilling
Xenalt Bulb W/Timer FOR 528305 528305XLT
14manufacturers in China registered for this device type
20catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (2), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Saikang Medical Equipment Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 34 |
| Jiangsu Yongfa Medical Equipment Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 33 |
| Shanghai NO. 2 Medical College Duhang Medical Equipment Factory | Shanghai | Shanghai | Contract manufacturer | 32 |
| Jiangsu Rooe Medical Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 31 |
| Better Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 24 |
| Shenyang Ourpromise Medical Equipment Co., Ltd. | Shenyang | Liaoning | Manufacturer | 24 |
| Hefei MT Medical Co., Ltd. | Hefei | Anhui | Manufacturer | 23 |
| Suzhou Number WIN Medical Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 16 |
| Hebei Webian Medical Instrument Trading Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 14 |
| Guangzhou Ajax Medical Equipment Co Ltd | Guangzhou | Guangdong | Manufacturer | 13 |
| Shanghai PAX Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 7 |
| Zhejiang Honsun Medical Technology Co., Ltd. | Wenzhou | Zhejiang | Manufacturer | 6 |
Showing 12 of 14. All 14 manufacturers in China registered for Lamp, Operating-Room
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | FQP |
| Device type | Lamp, Operating-Room |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4580 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-05-09 |
| Record revised | 2026-05-18 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN026676 | In distribution | |
| IPN026675 | In distribution | |
| IPN008828 | In distribution | |
| IPN026687 | In distribution | |
| IPN026679 | In distribution | |
| IPN008832 | In distribution | |
| IPN008846 | In distribution | |
| IPN008841 | In distribution | |
| IPN026673 | In distribution | |
| IPN008843 | In distribution | |
| IPN008831 | In distribution | |
| IPN008850 | In distribution | |
| IPN008833 | In distribution | |
| IPN008844 | In distribution | |
| IPN008848 | In distribution | |
| IPN008851 | In distribution | |
| IPN008838 | In distribution | |
| IPN008849 | In distribution | |
| IPN008840 | In distribution | |
| IPN008847 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SynFrame | Synthes Gmbh | 13 |
| SLS 9000 | Avante | 8 |
| Helux Pro Surgical Light | Baxter Medical Systems GmbH + Co. KG | 6 |
| SLS 2500 | Avante | 5 |
| Trumpf Medical | Baxter Medical Systems GmbH + Co. KG | 4 |
| SLS 6000 | Avante | 3 |
| Hillrom™ | Baxter Medical Systems GmbH + Co. KG | 3 |
| TruLight | Baxter Medical Systems GmbH + Co. KG | 3 |
| Lamp, Operating-Room | Synthes Gmbh | 2 |
| Jeashia | Zhejiang Honsun Medical Technology Co., Ltd. | 2 |
| iLED7 Surgical Light | Baxter Medical Systems GmbH + Co. KG | 2 |
| iLED | Baxter Medical Systems GmbH + Co. KG | 2 |
Showing 12 of 17. All products under Lamp, Operating-Room
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.