Instrapac
Instrapac Dental Exam Pack Plus with CPITN (WHO) Probe X40
15manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (4), Fujian (4), Jiangsu (3).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hynaut Health Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 68 |
| AID United International Co., Limited | Shanghai | Shanghai | Specification developer | 65 |
| Yiwu Ori-Power Medtech Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 46 |
| H&K International Trade Limited (China) | Jinhua | Zhejiang | Contract manufacturer | 29 |
| Wenzhou Zhusi Medical Supplies Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 27 |
| Zhejiang Longterm Medical Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 26 |
| Jiangsu Senwo Medical Technology Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 26 |
| Shanghai Chuangshi Medical Technology (Group) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 14 |
| Fujian Hui’an Hecheng Household Products Co., Ltd. | Quanzhou | Fujian | Manufacturer | 12 |
| Quanzhou V-Care Sanitary Products Co., Ltd. | Quanzhou | Fujian | Manufacturer | 10 |
| Jiangsu Moen Industrial Co., Ltd. | Suqian | Jiangsu | Manufacturer | 8 |
Showing 12 of 15. All 15 manufacturers in China registered for Nursing Pad, Hydrogel
Record
| Listed by | Robinson Healthcare Limited, United Kingdom |
|---|---|
| FDA product code | NTC |
| Device type | Nursing Pad, Hydrogel |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5630 |
| Establishment | Manufacturer |
| Record published | 2023-08-08 |
| Record revised | 2026-02-12 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep dry and keep out of direct sunlight |
| Packaging | Box of 40 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8883 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Momcozy | Shenzhen Lutejiacheng Supply Chain Management Co., Ltd. | 3 |
| Ameda ComfortGel Hydrogel Pads | Benq Materials Corporation | 1 |
| Gel Pack | Willow Innovations Inc. | 1 |
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.