GVS Technology (Suzhou) Co., Ltd.
Manufacturer and brand owner in Suzhou, Jiangsu, China. 5 device types, 29 products catalogued.
GVS Technology (Suzhou) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Spirometer, Diagnostic, Absorber, Carbon-Dioxide and 3 other device types. 29 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2010.
Registration
| Registered name | GVS Technology (Suzhou) Co., Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3005855942 |
| FEI number | 3005855942 |
| DUNS | 420798347 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | No.8 Taishan Road |
| Postal code | 215129 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Absorber, Carbon-Dioxide | Class 1 | CO2 Absorber, 1898/711KBSBB | 2020 | 6 |
| Accessory To Continuous Ventilator (Respirator) | Class 2 | 3700, 3800, 3500 In line filter | 2011 | 1 |
| Condenser, Heat And Moisture (Artificial Nose) | Class 1 | 9067/M/750, DYNJAAHME14, 4333/M/752, 9085/M/751, 9064/M/752, DYNJAAHME14-B and 22 more | 2011 | 29 |
| Filter, Bacterial, Breathing-Circuit | Class 2 | ServoDuoGuard, DYNJAAHME5, 9067/710, DYNJAAHME5-B, DYNJAAHME14-B, 7270 and 52 more | 2010 | 15 |
| Spirometer, Diagnostic | Class 2 | 1600, 100, PFT filters, 2800 | 2011 | 10 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| ECO Maxi filter | CAH | 2 |
| ECO Range – Maxi Series | BYD | 2 |
| ECO Range – Phase 1 | CAH | 2 |
| ECO Range – Maxi Series | CAH | 2 |
| 9065/M/710BRSA059/0001 | CAH | 1 |
| 9066/751BRSB074/0001 | BYD | 1 |
| 9080/750BRSA074/0001 | CAH | 1 |
| ECO Micro Hmef | CAH | 1 |
| 4244/M/711BRSA059/0001 | CAH | 1 |
| ECO Maxi HME | CAH | 1 |
| ECO Range – Micro Series | BYD | 1 |
| ECO Maxi Trachael HME | BYD | 1 |
| ECO Range – Midi Series | CAH | 1 |
| ECO Maxi HME | BYD | 1 |
| ECO Range – Mini Series | CAH | 1 |
| ECO Maxi Pleat – Pleated HEPA Filter | CAH | 1 |
| ECO Mini Hmef | CAH | 1 |
| ECO Range – Midi Series | BYD | 1 |
| 4333/M/711BRSA059/0001 | CAH | 1 |
| ECO Range | BYD | 1 |
| ECO Range – Mini Series | BYD | 1 |
| ECO HME | BYD | 1 |
| 9066/M/711BRSA059/0001 | CAH | 1 |
| 9064/M/711BRSA059/0001 | CAH | 1 |
| 9067/M/710BRSA059/0001 | CAH | 1 |
| 4333/M/712BRSA059/0001 | CAH | 1 |
| 9080/M/710BRSA | CAH | 1 |
| HEPA Filter | CAH | 1 |
| 9064/M/712BRSA059/0001 | CAH | 1 |
Clearances
No clearance names GVS Technology (Suzhou) Co., Ltd. as applicant. 3 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K051712 | 2005-09-01 | BZG | Traditional | Air Safety, Ltd. |
| K040712 | 2004-06-03 | MOD | Traditional | Air Safety, Ltd. |
| K033008 | 2004-05-13 | CAH | Traditional | Air Safety, Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2010 |
|---|---|
| Employees | Over 700 |
| Factory area | 30000 m² |
| Main products | Filter solutions, PCTE membranes, PTFE membranes, PVDF membranes |
| Certifications | ISO 13485, ISO-TS 16949, ISO 14001 |
| Export markets | Italy, UK, Brazil, USA, Mexico, Romania |
Nearby Manufacturers
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.
The manufacturer named here can complete this record.