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Sign in to claim this brandGVS Technology (Suzhou) Co., Ltd.
US
Last updated May 23, 2026
What GVS Technology (Suzhou) Co., Ltd. makes
GVS Technology produces single-use heat/moisture exchangers (HMEs) and microbial medical gas filters designed for respiratory care applications. Their HME devices, such as the ECO Maxi HME and ECO HME, are intended for use in ventilated patients to conserve heat and moisture in exhaled air. The company also supplies pleated HEPA filters, including the ECO Maxi Pleat, for filtering medical gases to reduce microbial contamination.
The company’s products are classified under FDA’s Class I and Class II categories, with listings in the FDA’s Unique Device Identifier (UDI) database. These devices are intended for use in the United States, adhering to regulatory requirements for medical gas filtration and respiratory therapy equipment. The manufacturer is based in the US.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does GVS Technology (Suzhou) Co., Ltd. manufacture?
GVS Technology (Suzhou) Co., Ltd. specializes in single-use medical devices for respiratory care. Their primary products include heat/moisture exchangers (HMEs), such as the ECO Maxi HME and ECO HME, which help conserve heat and moisture in exhaled air for ventilated patients. They also produce microbial medical gas filters, including pleated HEPA filters like the ECO Maxi Pleat, designed to filter medical gases and reduce microbial contamination. These devices are intended for use in clinical settings where clean air and moisture management are critical.
Where is GVS Technology (Suzhou) Co., Ltd. based, and what regulatory regions do their devices serve?
GVS Technology (Suzhou) Co., Ltd. is based in the United States. Their devices are listed in the FDA’s Unique Device Identifier (UDI) database, indicating compliance with U.S. regulatory requirements for medical devices. While the company’s headquarters is in the US, their products are specifically designed to meet the regulatory standards of the U.S. market for respiratory care and medical gas filtration.
Which regulatory registries or databases list GVS Technology’s devices?
GVS Technology’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system is used to track and identify medical devices in the United States, ensuring traceability and regulatory compliance. Listing in this database helps healthcare providers and regulators verify the identity and classification of the company’s products.
How are GVS Technology’s devices classified under U.S. regulations?
GVS Technology’s devices fall under two classification categories in the U.S.: Class I and Class II. Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The company’s heat/moisture exchangers and microbial medical gas filters are categorized based on their intended use and potential risk to patients, with Class II likely applying to devices with more complex functions or higher risk, such as certain filters.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 420798347
Catalogue (33)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ECO Range | 62.002.0086.9066/751RRSA | FDA UDI | Class I | Active |
| ECO Maxi Filter | 62.002.0074.4222/701RRSA | FDA UDI | Class II | Active |
| ECO Maxi HME | 62.002.0101.4333/751RRSA | FDA UDI | Class I | Active |
| Eco Hme | 9080/750 Resmed 27922 Rev01 | FDA UDI | Class I | Active |
| ECO Range - Maxi Series | 62.002.0135.4333/751BRSA | FDA UDI | Class I | Active |
| ECO Maxi Trachael HME | 62.002.0128.9500/750RRSA | FDA UDI | Class I | Active |
| ECO Maxi Pleat - Pleated HEPA Filter | 62.002.0095.4244/702CRSA | FDA UDI | Class II | Active |
| 4333/M/711brsa059/0001 | DYNJAAHME1 | FDA UDI | Class II | Active |
| 9066/751brsb074/0001 | 62.002.0086.9066/751CRSA | FDA UDI | Class I | Active |
| ECO Range - Maxi Series | 62.002.0079.4244/711CRSA | FDA UDI | Class II | Active |
| 9064/M/712brsa059/0001 | DYNJAAHME11 | FDA UDI | Class II | Active |
| ECO Micro HMEF | 62.002.0080.9080/710RRSA | FDA UDI | Class II | Active |
| ECO Range - Maxi Series | 62.002.0070.4333/710CRSA | FDA UDI | Class II | Active |
| ECO Range Phase 1 | 62.002.0134.8866/50BRSA | FDA UDI | Class II | Active |
| ECO Range - Phase 1 | 62.002.0017.8866/100CRSA | FDA UDI | Class II | Active |
| ECO Range - Mini Series | 62.002.0087.9067/710CRSA | FDA UDI | Class II | Active |
| HEPA Filter | 4244-701 BRSA | FDA UDI | Class II | Active |
| ECO Mini HMEF | 62.002.0084.9066/711RRSA | FDA UDI | Class II | Active |
| ECO Range - Midi Series | 62.002.0133.9065/750BRSA | FDA UDI | Class I | Active |
| ECO Range - Mini Series | 62.002.0089.9067/750BRSB | FDA UDI | Class I | Active |
| 9066/M/711brsa059/0001 | DYNJAPHME17 | FDA UDI | Class II | Active |
| 9080/M/710brsa | DYNJAPHME21 | FDA UDI | Class II | Active |
| 9064/M/711brsa059/0001 | DYNJAAHME9 | FDA UDI | Class II | Active |
| ECO Range - Maxi Series | 62.002.0131.4333/750BRSA | FDA UDI | Class I | Active |
| 9065/M/710brsa059/0001 | DYNJAAHME13 | FDA UDI | Class II | Active |
| ECO Maxi HME | 62.002.0075.4333/711RRSA | FDA UDI | Class II | Active |
| 4333/M/712brsa059/0001 | DYNJAAHME5 | FDA UDI | Class II | Active |
| 9080/750brsa074/0001 | 62.002.0132.9080/750BRSA | FDA UDI | Class II | Active |
| ECO Maxi filter | 4222/701BSSA | FDA UDI | Class II | Active |
| 9067/M/710brsa059/0001 | DYNJAPHME19 | FDA UDI | Class II | Active |
| ECO Range - Midi Series | 62.002.0090.9064/711CRSA | FDA UDI | Class II | Active |
| ECO Range - Micro Series | 62.002.0083.9085/751CRSA | FDA UDI | Class I | Active |
| 4244/M/711brsa059/0001 | DYNJAAHMEHEPA | FDA UDI | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- GVS Technology (Suzhou) Co., Ltd Suzhou Jiangsu · CN FEI 3005855942