Neuropen Monofilaments 10g
Monofilaments for neuropathy screening
9manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (3), Hubei (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 |
|---|---|---|---|---|
| Hubei Dacheng Medical Technology Co., Ltd. | Xianning | Hubei | Contract manufacturer | 12 |
| Rongxing Plastic Jurong Co., Ltd. | Zhenjiang | Jiangsu | Contract manufacturer | 8 |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Ningbo Castle Medical Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 67 |
| Suzhou Pipi Medical Products Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 48 |
| Wenzhou Caretek Medical Device Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 30 |
| Ruian Sunnyworld International Trade Co., Ltd. | Ruian | Zhejiang | Manufacturer | 10 |
| Perfect Group Corp. Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 9 |
| Guangzhou Goldsun Electronic Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Owen Mumford Limited, United Kingdom |
|---|---|
| FDA product code | GXB |
| Device type | Esthesiometer |
| Device class | Class 1 |
| Regulation | 21 CFR 882.1500 |
| Establishment | Contract manufacturer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-10-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment temperature 5 to 40 °C |
| Packaging | Case of 20, sleeve of 5 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| NT 0104 | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| The Pinprick | MRC Systems Gmbh Medizintechnische Systeme | 16 |
| Medipin | Medipin Limited | 2 |
| Bailey Retractable Monofilament 10g | Bailey Instruments Ltd | 1 |
| Neuro Touch | Yostra Labs Private Limited | 1 |
| Neurotips | Owen Mumford Limited | 1 |
| Neuropen | Owen Mumford Limited | 1 |
| Darco® Foot Filament | Darco International, Inc. | 1 |
| Darco® Monofilament Tester | Darco International, Inc. | 1 |
| OptiHair2 | MRC Systems Gmbh Medizintechnische Systeme | 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.