Coloplast
60 catalogue numbers from ACP606, listed by Coloplast A/S, Denmark, under Catheter, Ureteral, Gastro-Urology. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
60catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Guangdong (1), Shanghai (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 |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Well Lead Medical (Hainan) Co., Ltd. | Haikou | Hainan | Contract manufacturer | 3 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Amsino Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 22 |
Record
| Listed by | Coloplast A/S, Denmark |
|---|---|
| FDA product code | EYB |
| Device type | Catheter, Ureteral, Gastro-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2024-04-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Packaging | Retail box of 5, shipper box of 59, shipper box of 34 |
| Sizes | Catheter gauge 3 to 12 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ACP606 | Catheter Gauge 6 Fr | In distribution |
| ACR205 | Catheter Gauge 5 Fr | In distribution |
| ACP307 | Catheter Gauge 7 Fr | In distribution |
| ACP205 | Catheter Gauge 4.8 Fr | In distribution |
| ACP304 | Catheter Gauge 4 Fr | In distribution |
| ACR206 | Catheter Gauge 6 Fr | In distribution |
| AC5909 | Catheter Gauge 9 Fr | In distribution |
| ACP205 | Catheter Gauge 4.8 Fr | In distribution |
| ACP305 | Catheter Gauge 4.8 Fr | In distribution |
| ACP603 | Catheter Gauge 3 Fr | In distribution |
| AC5C07 | Catheter Gauge 7 Fr | In distribution |
| ACP208 | Catheter Gauge 8 Fr | In distribution |
| ACP306 | Catheter Gauge 6 Fr | In distribution |
| ACP604 | Catheter Gauge 4 Fr | In distribution |
| AC5905 | Catheter Gauge 5 Fr | In distribution |
| ACP303 | Catheter Gauge 3 Fr | In distribution |
| ACP206 | Catheter Gauge 6 Fr | In distribution |
| AC5905 | Catheter Gauge 5 Fr | In distribution |
| ACP307 | Catheter Gauge 7 Fr | In distribution |
| ACP406 | Catheter Gauge 6 Fr | In distribution |
| ACP604 | Catheter Gauge 4 Fr | In distribution |
| AC5904 | Catheter Gauge 4 Fr | In distribution |
| ACP403 | Catheter Gauge 3 Fr | In distribution |
| ACP405 | Catheter Gauge 4.8 Fr | In distribution |
| ACP208 | Catheter Gauge 8 Fr | In distribution |
| ACP406 | Catheter Gauge 6 Fr | In distribution |
| ACR207 | Catheter Gauge 7 Fr | In distribution |
| AC5911 | Catheter Gauge 11 Fr | In distribution |
| ACP403 | Catheter Gauge 3 Fr | In distribution |
| AC5910 | Catheter Gauge 10 Fr | In distribution |
| ACP605 | Catheter Gauge 4.8 Fr | In distribution |
| AC5908 | Catheter Gauge 8 Fr | In distribution |
| ACP206 | Catheter Gauge 6 Fr | In distribution |
| AC5906 | Catheter Gauge 6 Fr | In distribution |
| AC5910 | Catheter Gauge 10 Fr | In distribution |
| AC5906 | Catheter Gauge 6 Fr | In distribution |
| ACP407 | Catheter Gauge 7 Fr | In distribution |
| AC5912 | Catheter Gauge 12 Fr | In distribution |
| ACP407 | Catheter Gauge 7 Fr | In distribution |
| ACP303 | Catheter Gauge 3 Fr | In distribution |
| AC5909 | Catheter Gauge 9 Fr | In distribution |
| ACP606 | Catheter Gauge 6 Fr | In distribution |
| AC5912 | Catheter Gauge 12 Fr | In distribution |
| ACP607 | Catheter Gauge 7 Fr | In distribution |
| AC5908 | Catheter Gauge 8 Fr | In distribution |
| ACP404 | Catheter Gauge 4 Fr | In distribution |
| ACP306 | Catheter Gauge 6 Fr | In distribution |
| ACP207 | Catheter Gauge 7 Fr | In distribution |
| AC5907 | Catheter Gauge 7 Fr | In distribution |
| AC5907 | Catheter Gauge 7 Fr | In distribution |
| AC5904 | Catheter Gauge 4 Fr | In distribution |
| ACP603 | Catheter Gauge 3 Fr | In distribution |
| AC5911 | Catheter Gauge 11 Fr | In distribution |
| ACP305 | Catheter Gauge 4.8 Fr | In distribution |
| ACP405 | Catheter Gauge 4.8 Fr | In distribution |
| ACP304 | Catheter Gauge 4 Fr | In distribution |
| ACP605 | Catheter Gauge 4.8 Fr | In distribution |
| ACP207 | Catheter Gauge 7 Fr | In distribution |
| ACP404 | Catheter Gauge 4 Fr | In distribution |
| ACP607 | Catheter Gauge 7 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Porges Coloplast | Coloplast A/S | 32 |
| Bard® Woven Ureteral Catheter | C.R. Bard, Inc. | 31 |
| Pigtail | Cook Incorporated | 18 |
| Sof-Flex | Cook Incorporated | 11 |
| AMSure® Red Rubber Urethral Catheter | Amsino Medical Inc. | 11 |
| Medline | Medline Industries, Inc. | 11 |
| Red Rubber Urethral Catheters | Dynarex Corp. | 9 |
| Bard® Polyurethane Ureteral Catheters, Open Tip | C.R. Bard, Inc. | 9 |
| TruCath | HR Pharmaceuticals Inc. | 8 |
| Cook | Cook Incorporated | 4 |
| Flexi-Tip | Cook Incorporated | 4 |
| Dornier MedTech | Dornier Medtech America, Inc. | 4 |
Showing 12 of 38. All products under Catheter, Ureteral, Gastro-Urology
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.