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Non-Rebreathing Valve
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref ERM0106002Model 15mmOD510(k) K171961Ref ERM0106001Model 18mmOD
Identity
- Trade Name
- Non-Rebreathing Valve EUDAMED
- Device Name
- Non-Rebreathing Valve EUDAMED
- Model / Reference
- 15mmOD EUDAMEDERM0106002 EUDAMED18mmOD EUDAMEDERM0106001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06946430419200 EUDAMED06946430419217 EUDAMED
- Basic UDI-DI
- 694643041433201MW EUDAMED694643041433202MY EUDAMED
- 510(k) Number
- K171961 FDA 510(k)
- FDA Product Code
- CBP FDA 510(k)
- EMDN Code
- R03010180 ARTIFICIAL VENTILATION MASKS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5870 FDA 510(k)
- Regulation Number
- 868.5870 FDA 510(k)
- Market of Registration
- Italy EUDAMED
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
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
Non-Rebreathing Valve by Xiamen Compower Medical Tech. Co., Ltd. — Class I — MDD, FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 694643041433201MW | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K171961 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 694643041433201MW | Class I | Active |
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Manufacturer
- Manufacturer
- Xiamen Compower Medical Tech. Co., Ltd.
- EUDAMED SRN
- CN-MF-000011703
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (3)
- EUDAMED 0c3b4add-0fda-45ed-aeef-e35e2b7f4691 61 fields · synced Aug 2, 2026
- FDA 510(k) K171961 24 fields · synced May 18, 2026
- EUDAMED 5ea97985-b7cc-40e7-a028-e0e2a4fdd95a 61 fields · synced Jul 19, 2026