Darco® Foot Filament
Darco® Foot Filament: 1 catalogue number listed by Darco International, Inc., United States, under Esthesiometer. 9 manufacturers in China are registered for this product code.
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 | Darco International, Inc., United States |
|---|---|
| FDA product code | GXB |
| Device type | Esthesiometer |
| Device class | Class 1 |
| Regulation | 21 CFR 882.1500 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-02-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FF | 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 |
| Neuropen Monofilaments 10g | Owen Mumford Limited | 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.