DeRoyal
Covaderm Plus GTLDrsg 4x4 VADSilicone Composite Dressing
195manufacturers in China registered for this device type
170catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Zhejiang (55), Jiangsu (42), Guangdong (32). 33 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Hubei V-Medical Products Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 46 |
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| Shanghai Care Us Medical Product Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 30 |
| Planet (Anhui) Medical Products Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 30 |
| Jinhua Jingdi Medical Supplies Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 29 |
| Weihai Kangzheng Medical Equipments Technology Co., Ltd. | Weihai | Shandong | Contract manufacturer | 26 |
| Nanjing 3H Medical Products Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 25 |
| Yiwu Haoding Medical Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 23 |
| Changzhou Recoo Healthcare Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 19 |
| Henso Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Huizhou Foryou Medical Devices Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 18 |
Showing 12 of 195. All 195 manufacturers in China registered for Dressing, Wound, Hydrophilic
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | NAC |
| Device type | Dressing, Wound, Hydrophilic |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4018 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-02-02 |
| Record revised | 2024-10-08 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 20, box of 10, case of 10, case of 5, box of 25, case of 50 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 46-403S | In distribution | |
| 46-105 | In distribution | |
| NP-907B | In distribution | |
| 46-713-1 | In distribution | |
| 46-375 | In distribution | |
| 46-405 | In distribution | |
| 46-125 | In distribution | |
| 46-405N | In distribution | |
| 46-102 | In distribution | |
| 46-400-1 | In distribution | |
| 46-124 | In distribution | |
| 46-408-1 | In distribution | |
| NP-200-EU | In distribution | |
| 15-305 | In distribution | |
| 46-166 | In distribution | |
| 46-928 | In distribution | |
| 46-151 | In distribution | |
| 46-400N | In distribution | |
| 46-926 | In distribution | |
| 46-401N | In distribution | |
| 46-129 | In distribution | |
| 46-411S | In distribution | |
| 46-001N | In distribution | |
| 46-945 | In distribution | |
| 46-403-1 | In distribution | |
| NP-201 | In distribution | |
| NP-203-EU | In distribution | |
| 46-109 | In distribution | |
| 46-LT20 | In distribution | |
| 46-916-1 | In distribution | |
| 46-103 | In distribution | |
| 32-700 | In distribution | |
| 46-004 | In distribution | |
| 46-104 | In distribution | |
| 46-137 | In distribution | |
| 46-103N | In distribution | |
| 46-001-1 | In distribution | |
| NP-202 | In distribution | |
| NP-906B | In distribution | |
| 46-002 | In distribution | |
| 15-304 | In distribution | |
| 46-135 | In distribution | |
| 46-157 | In distribution | |
| 46-130 | In distribution | |
| 46-371 | In distribution | |
| 46-LT20S-120 | In distribution | |
| 46-102-1 | In distribution | |
| 46-003-1 | In distribution | |
| 46-113 | In distribution | |
| 46-131EU | In distribution | |
| 46-907 | In distribution | |
| 46-002N | In distribution | |
| NP-204 | In distribution | |
| 46-415 | In distribution | |
| 46-013 | In distribution | |
| 46-101-1 | In distribution | |
| 46-407N | In distribution | |
| 46-110 | In distribution | |
| 050-1043 | In distribution | |
| 46-123EU | In distribution | |
| 46-401-1 | In distribution | |
| 46-122 | In distribution | |
| 46-915 | In distribution | |
| 46-004-1 | In distribution | |
| 46-400 | In distribution | |
| 15-302 | In distribution | |
| 46-LT20S-04 | In distribution | |
| NP-203 | In distribution | |
| 46-916 | In distribution | |
| 46-160 | In distribution | |
| 46-908 | In distribution | |
| NP-206 | In distribution | |
| 46-116 | In distribution | |
| 46-LT19S-01B | In distribution | |
| 46-002-1 | In distribution | |
| 46-106 | In distribution | |
| 46-405-1 | In distribution | |
| 46-001 | In distribution | |
| 46-014 | In distribution | |
| 46-411 | In distribution | |
| 46-123 | In distribution | |
| 46-101 | In distribution | |
| 10-6578 | In distribution | |
| 46-408N | In distribution | |
| 46-106-1 | In distribution | |
| 46-005N | In distribution | |
| 15-204 | In distribution | |
| 46-134 | In distribution | |
| 46-406 | In distribution | |
| NP-205 | In distribution | |
| 46-004N | In distribution | |
| 46-121 | In distribution | |
| 46-402 | In distribution | |
| 46-012 | In distribution | |
| 15-301N | In distribution | |
| 46-159 | In distribution | |
| 46-127 | In distribution | |
| 46-405S | In distribution | |
| 46-011 | In distribution | |
| 46-126 | In distribution | |
| 46-420N | In distribution | |
| 46-411-1 | In distribution | |
| 46-408S | In distribution | |
| 15-201 | In distribution | |
| 46-401 | In distribution | |
| 46-115 | In distribution | |
| 46-908B | In distribution | |
| 46-158 | In distribution | |
| 46-155 | In distribution | |
| 46-132 | In distribution | |
| 32-1362 | In distribution | |
| 46-156 | In distribution | |
| NP-200 | In distribution | |
| 46-108 | In distribution | |
| 46-927 | In distribution | |
| 46-003N | In distribution | |
| 46-908-1 | In distribution | |
| NP-202-EU | In distribution | |
| 46-372 | In distribution | |
| 050-1048 | In distribution | |
| 46-LT20S-30 | In distribution | |
| 46-133 | In distribution | |
| 15-203 | In distribution | |
| 46-402-1 | In distribution | |
| NP-908B | In distribution | |
| 46-906 | In distribution | |
| 46-114 | In distribution | |
| 46-412S | In distribution | |
| 46-906-1 | In distribution | |
| 46-401S | In distribution | |
| 46-131 | In distribution | |
| 46-402S | In distribution | |
| 46-LT5S-05 | In distribution | |
| 46-929 | In distribution | |
| 15-306 | In distribution | |
| 46-414 | In distribution | |
| 46-403 | In distribution | |
| 46-374 | In distribution | |
| 15-202 | In distribution | |
| 46-713 | In distribution | |
| 46-102N | In distribution | |
| 46-925 | In distribution | |
| 47-951 | In distribution | |
| 15-205 | In distribution | |
| 46-128 | In distribution | |
| 46-408 | In distribution | |
| 15-301 | In distribution | |
| 15-303 | In distribution | |
| 46-915-1 | In distribution | |
| 46-005-1 | In distribution | |
| NP-205-EU | In distribution | |
| 46-LT19S-04 | In distribution | |
| 46-LT13 | In distribution | |
| 46-165 | In distribution | |
| 46-162 | In distribution | |
| 46-003 | In distribution | |
| 46-112 | In distribution | |
| NP-201-EU | In distribution | |
| 46-153 | In distribution | |
| 32-188 | In distribution | |
| NP-204-EU | In distribution | |
| NP-206-EU | In distribution | |
| 46-905 | In distribution | |
| 15-302N | In distribution | |
| 46-005 | In distribution | |
| 46-111 | In distribution | |
| 46-107 | In distribution | |
| 46-152 | In distribution | |
| 46-138 | In distribution | |
| 46-406S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Simpurity | Safe N Simple LLC | 91 |
| AMD-Ritmed ALL Gauze | AMD Medicom Inc. | 80 |
| 3M™ Tegaderm™ | 3M Company | 78 |
| Cutimed® Sorbion® | BSN Medical, Inc. | 70 |
| AMD-Ritmed | AMD Medicom Inc. | 63 |
| Medline | Medline Industries, Inc. | 56 |
| Dododots | Dodo Ventures SDN. BHD | 42 |
| Aquacel Foam | Convatec, Purchasing Department | 39 |
| McKesson | Mckesson Medical-Surgical Inc. | 37 |
| Vitale | CellEra, LLC | 36 |
| MedVance | MED WAY Inc. | 36 |
| ProCure | Twin Med, LLC | 35 |
Showing 12 of 432. All products under Dressing, Wound, Hydrophilic
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-05-18 | Class II | Under Investigation by firm | Sterile wound dressing, lacks sterility assurance | 800 units | |
| 2004-01-19 | Not classified | Other | Hydrophilic powder wound dressing, sterilized at a dosage which subsequently failed a sterility audit, was distributed. | 2,495 units | 2004-10-13 |
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.