NuRoo
Baby carrier
7manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (3), Shandong (1), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Lingxian Dongsheng Textile Co., Ltd. | Dezhou | Shandong | Contract manufacturer | 23 |
| Dalian Sportech Apparel Co., Ltd. | Dalian | Liaoning | Contract manufacturer | 1 |
| Foshan Nanhai Jianli Underwear Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 1 |
| Ningbo MPF Manufacturing Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 35 |
| Zhejiang Rehan Medical Manufacturing Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 20 |
| Viecura Medical Group Limited | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Shaoxing Intai Garment Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 1 |
Record
| Listed by | Brownmed, United States |
|---|---|
| FDA product code | HEF |
| Device type | Binder, Breast |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5160 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-08-13 |
| Record revised | 2020-09-28 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Distribution end date | 2020-09-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 08030 | Withdrawn | |
| 08000 | Withdrawn | |
| 08006 | Withdrawn | |
| 08005 | Withdrawn | |
| 08008 | Withdrawn | |
| 08007 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 13 |
| Dale Post Surgical Bra | Dale Medical Products, Inc. | 11 |
| Dale Post Surgical Compression Bra | Dale Medical Products, Inc. | 5 |
| Centurion | Centurion Medical Products Corporation | 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.