Moldcare RI II
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2manufacturers in China registered for this device type
11catalogue numbers in this listing
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangdong Meicen Medical Equipment Co., Ltd. | Foshan | Guangdong | Manufacturer | 7 |
| Guangzhou Tian Hong Medical Technology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 4 |
Record
| Listed by | Alcare Co., Ltd. |
|---|---|
| FDA product code | KXH |
| Device type | Cradle, Patient, Radiologic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1830 |
| Premarket notification | Exempt |
| Record published | 2025-06-24 |
| Record revised | 2025-06-18 (version 5) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Handling environment temperature 15 to 25 °C; Storage environment temperature 15 to 25 °C; Special storage condition: Do not use if package is damaged.; Special storage condition: Keep away from sunlight.; Special storage condition: Keep dry. |
| Packaging | Pack of 50, pack of 20, pack of 25, pack of 6, pack of 10 |
| Sizes | Length 20 to 60 cm; width 15 to 60 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HN S | Upper Base: 30cm Lower Base: 58cm Height: 55cm | In distribution |
| HN TR | Trapezoid shape, Upper Base 5cm/ Lower base 58cm/ Height 65cm | In distribution |
| HN U | Length 35 cm | In distribution |
| HN 0.5 | Length 20 cm | In distribution |
| BR3 | Length 60 cm | In distribution |
| HN UT | Trapezoid Sape, Upper Base 20cm/Lower Base 58cm/Height 47cm | In distribution |
| HN 1 | Length 20 cm | In distribution |
| HN E | Trapezoid shape, Upper Base 7cm/ Lower base 20cm/ Height 34cm | In distribution |
| HN C | Upper Base: 12cm Lower Base: 20cm Height: 35cm | In distribution |
| HN 2 | Length 20 cm | In distribution |
| BR1 | Length 40 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| pearltec | Pearl Inc. | 27 |
| ProFoam | Pearl Inc. | 22 |
| Moldcare | IZI Medical Products LLC | 6 |
| AccuBoost | Advanced Radiation Therapy, LLC | 5 |
| PearlFit | Pearl Inc. | 3 |
| ProBelt | Pearl Inc. | 2 |
| ProFoam Wedge 18x23x10 30° | Pearl Inc. | 1 |
| ProBelt 50 VH | Pearl Inc. | 1 |
| PearlFit Inlay Head | Pearl Inc. | 1 |
| ProBelt 350 Wrap | Pearl Inc. | 1 |
| Small U Head Cushions | Octostop, Inc. | 1 |
| FoamFit Plate 18x8x2 | Pearl Inc. | 1 |
Showing 12 of 137. All products under Cradle, Patient, Radiologic
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.