Helmut Zepf
Textile Filter (Pack OF 1 PCE) FOR Sterilisation Containers 85.327.00, 85.327.10, 85.327.20 &
22manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (12), Zhejiang (5), Guangdong (5). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Suzhou Texnet | Suzhou | Jiangsu | Contract manufacturer | 47 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Meifu Medical Technology Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 13 |
| JIE GAO Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 11 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Ningbo Just Soon Industrial Limited | Ningbo | Zhejiang | Repacker / relabeller | 36 |
| Ningbo Unico Products Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 35 |
| Nanjing 3H Medical Products Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 25 |
Showing 12 of 22. All 22 manufacturers in China registered for Bath, Sitz, Nonpowered
Record
| Listed by | Helmut Zepf Medizintechnik Gmbh, Germany |
|---|---|
| FDA product code | KTC |
| Device type | Bath, Sitz, Nonpowered |
| Device class | Class 1 |
| Regulation | 21 CFR 890.5125 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2022-12-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 85.327.40 | In distribution | |
| 85.327.60 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Drivemedical | Drive DeVilbiss Healthcare | 4 |
| CHS | Canadian Hospital Specialties Ltd. | 3 |
| TR900CWA HI LO 230V Cleaning, Autofill & Whirlpool GE | TR Equipment AB | 2 |
| TR Swing Bath Recling Bath TMV2 | TR Equipment AB | 2 |
| DS PrimeTaper | Dentsply Implants Manufacturing GmbH | 2 |
| Hilo Bath TR900 C TMV3 with stainless Bathtub | TR Equipment AB | 1 |
| Medtronic Cases and Trays | Medtronic Sofamor Danek, Inc. | 1 |
| TR900CA HI LO 110V Cleaning & Autofill US | TR Equipment AB | 1 |
| TR900C HI LO 230V Cleaning | TR Equipment AB | 1 |
| TR900 HI LO 230V Risk 5 TMV3 | TR Equipment AB | 1 |
| TR900 HI LO 230V GE | TR Equipment AB | 1 |
| Comfortline HI LO 230V, 50mm drain and pipe interrupter | TR Equipment AB | 1 |
Showing 12 of 76. All products under Bath, Sitz, Nonpowered
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.