DeRoyal
Amniotic Membrane Perforator
5manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (1), Fujian (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Jiangsu Suyun Medical Materials Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 11 |
| Zhangzhou Aoxi Plastic Co., Ltd. | Zhangzhou | Fujian | Manufacturer | 7 |
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | HGE |
| Device type | Amniotome |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4530 |
| 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 100, box of 25, case of 500 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 72-7100 | In distribution | |
| 72-7100NS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Amnicot | GO Medical Industries PTY. Ltd. | 2 |
| Arom-COT | Utah Medical Products, Inc. | 2 |
| MedGyn Disposable Amnio Hook | Medgyn Products, Inc. | 1 |
| mityhook | Coopersurgical, Inc. | 1 |
| Quinelato | Schobell Industrial Ltda | 1 |
| Amnihook Amniotic Membrane Perforator | Aspen Surgical Products, Inc. | 1 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 1 |
| Gimmi | Gimmi Gmbh | 1 |
| Aesculap | Aesculap AG | 1 |
| Mabis DMI | D-M-S Holdings, Inc. | 1 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 1 |
| ObstiHook | Cook Incorporated | 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.