Explorer Ball Module STD With Spacer
Catalogue number 0103(1/2)xxx, listed by macu4 GmbH, Germany, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (2), Hebei (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Dongguan Supercare Medical Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 41 |
| Hengshui Gangsheng Medical Instruments Co., Ltd. | Hengshui | Hebei | Contract manufacturer | 36 |
| Huzhou Universal Glove Company Limited | Huzhou | Zhejiang | Manufacturer | 10 |
Record
| Listed by | macu4 GmbH, Germany |
|---|---|
| FDA product code | ISZ |
| Device type | Unit, Wrist, External Limb Component, Mechanical |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3420 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-11-23 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0103(1/2)xxx | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Wrist | Hugh Steeper Ltd | 37 |
| Taska Lamination Collar Kit (6-band), 45mm, Black | Taska Prosthetics | 1 |
| Explorer Twin Module LRG with spacer | macu4 GmbH | 1 |
| Explorer Pinch Module spacer | macu4 GmbH | 1 |
| Taska Seal Ring Kit, 50mm, Black | Taska Prosthetics | 1 |
| Explorer Hold Lock Module | macu4 GmbH | 1 |
| Explorer Bike Module STD with spacer | macu4 GmbH | 1 |
| Explorer Ring STD | macu4 GmbH | 1 |
| Explorer Twin Module STD with spacer | macu4 GmbH | 1 |
| Low Profile Lamination Kit, CX, 50mm | Taska Prosthetics | 1 |
| Explorer Swim Module SML without spacer | macu4 GmbH | 1 |
| Medi | Medi Manufacturing Inc | 1 |
Showing 12 of 35. All products under Unit, Wrist, External Limb Component, Mechanical
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.