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Smoke Evacuation Filter
EUDAMEDClass I (EU MDR)
Ref PS030105Ref PS03B102Ref PS030103Ref PS03B301
Identity
- Trade Name
- Smoke Evacuation Filter EUDAMED
- Device Name
- Smoke Evacuation Filter EUDAMED
- Model / Reference
- PS030105 EUDAMEDPS03B102 EUDAMEDPS030103 EUDAMEDPS03B301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923310910101 EUDAMED06923310916042 EUDAMED06923310916165 EUDAMED06923310916073 EUDAMED
- Basic UDI-DI
- 69233109PS03PN EUDAMED
- EMDN Code
- R040199 VENTILATION FILTERS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Microbial medical gas filter, single-use
The Smoke Evacuation Filter is a cutting-edge medical device designed to rapidly remove smoke and other contaminants from the air, providing improved patient care and outcomes in high-risk environments.
Similar devices
Also classified as Microbial medical gas filter, single-use.
- ECO slimline — GVS Filter Technology UK Ltd · Class IIa
- Disposable Heat and Moisture Exchanger Filters — NINGBO HUAKUN MEDICAL EQUIPMENT CO.,LTD · Class IIa
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- Ventlab — Ventlab Corp. · Class II
- Disposable Heat and Moisture Exchanger Filters — NINGBO HUAKUN MEDICAL EQUIPMENT CO.,LTD · Class IIa
- Ventlab — Ventlab Corp. · Class II
- Pentair — Pentair Filtration Solutions · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69233109PS03PN | Class I | Active |
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Manufacturer
- Manufacturer
- Hangzhou Formed Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000011212
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (4)
- EUDAMED 6d1eb6d2-a923-4579-8548-169a3a414fa8 61 fields · synced Jul 27, 2026
- EUDAMED 6adc2a10-5673-40af-a49e-6e1096c8aae0 61 fields · synced May 17, 2026
- EUDAMED 21e5937a-2e61-4cee-ae88-0d9c19f44b3a 61 fields · synced May 18, 2026
- EUDAMED 4ab132ba-9434-4d8b-9caa-dba73fe34fc4 61 fields · synced May 18, 2026