DeRoyal
Anatomical Nasal Dressing W/String
6manufacturers in China registered for this device type
14catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (4), Tianjin (1), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Huizhou Foryou Medical Devices Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 18 |
| Jcmed Tianjin Import AND Export Co., Ltd. | Tianjin | Tianjin | Manufacturer | 51 |
| Shenzhen JPY ION-Tech. Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
| Guangdong Tidakang Medical Technology Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 12 |
| Guangzhou Kaiheng K&S Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 9 |
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | EMX |
| Device type | Balloon, Epistaxis |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4100 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-07-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 34-401 | In distribution | |
| 34-302 | In distribution | |
| 34-201 | In distribution | |
| 34-402 | In distribution | |
| 34-107 | In distribution | |
| 34-303 | In distribution | |
| 34-102 | In distribution | |
| 34-103 | In distribution | |
| 34-105 | In distribution | |
| 34-106 | In distribution | |
| 34-104 | In distribution | |
| 34-306 | In distribution | |
| 34-202 | In distribution | |
| 34-101 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Osseous | EON Meditech PVT. Ltd. | 123 |
| Ultracell® | Beaver-Visitec International, Ltd | 51 |
| Gyrus Acmi | Gyrus Acmi, Inc. | 50 |
| Fabco | First AID Bandage Co Inc | 17 |
| Epistax Balloon Catheter | Summit Medical LLC | 12 |
| Rapid Rhino | Smith & Nephew, Inc. | 12 |
| Netcell | Network Medical Products, Ltd. | 8 |
| Rhinocell® Nasal Packing | Boston Medical Products, Inc. | 8 |
| Rhino Rocket | Gyrus Acmi, Inc. | 4 |
| Epi-Max™ Epistaxis Procedure Pack | Boston Medical Products, Inc. | 4 |
| Nose It All | Product Motif Inc. | 4 |
| Merogel Nasal Dressing/Sinus Stent &Otologic Packing 4x4cm | Anika Therapeutics, Inc. | 4 |
Showing 12 of 47. All products under Balloon, Epistaxis
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.