Kmedic
2 catalogue numbers from IPN015583, listed by Teleflex Medical LLC, United States, under Forceps, Biopsy, Gynecological. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (3), Guangdong (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Guangdong MacroLux Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Hangzhou Stellarmed Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 15 |
| Zhuji Pengtian Medical Instrument Co., Ltd. | Zhuji | Zhejiang | Manufacturer | 10 |
| Macrolux Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Jiangsu Jiyuan Medical Technology Co., Ltd. | Taizhou | Jiangsu | Specification developer | 3 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | HFB |
| Device type | Forceps, Biopsy, Gynecological |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-15 |
| Record revised | 2026-02-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 203 to 229 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN015583 | Length 229 mm | In distribution |
| IPN015584 | Length 203 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endoch | Endoch Inc | 160 |
| Marina Medical | Marina Medical Instruments, Inc. | 142 |
| Gynex | Gynex Corporation | 64 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 52 |
| Aesculap | Aesculap AG | 49 |
| Novo Surgical | Novo Surgical, Inc. | 44 |
| Hayden Medical | Hayden Medical Inc | 37 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 34 |
| BR Surgical, LLC | BR Surgical LLC | 33 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 29 |
| Raw Surgical Corporation | RAW Surgical Corporation | 26 |
| Millennium | Avalign Technologies, Inc. | 24 |
Showing 12 of 131. All products under Forceps, Biopsy, Gynecological
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.