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AeroChamber Plus*
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref 101502Ref 108508/108508110035Ref 108508/10850882050Ref 108507/108507110070Ref 108509/108509119070Model 108509Ref 108504/108504115035Ref 108504/108504117050Ref 108504/10850482050Ref 101503Ref 108509/108509110060Ref 108501/10850184060Model 108501Ref 108509/108509115050Ref 108509/108509115060Ref 101504Ref 108509/10850982050Ref 108508/10850884035Ref 108501/108501114060Ref 108509/108509117050Ref 108504/108504119050Ref 108507/10850784070Ref 108501 / 108501110060Ref 108508/108508119050Ref 108507/10850782080Ref 108507/108507119090Ref 108502/10850282080Ref 108502/108502119090Ref 108509/10850984060Ref 108507/108507109070Ref 108508/108508115050Ref 87501Ref 108502/108502117080Ref 108508/108508115035510(k) K181649Ref 108502/108502115070Ref 108502/108502115080Ref 108504/108504114035Ref 108501/108501119070
Identity
- Trade Name
- AeroChamber Plus* EUDAMEDAEROCHAMBER PLUS FLOW-VU EUDAMEDAeroChamber* EUDAMED
- Device Name
- Valved Holding Chamber EUDAMEDAeroChamber Plus* Flow-Vu* 5+ years Youth Mouthpiece EUDAMEDAeroChamber Plus* Flow-Vu*, 5+ Years Youth EUDAMEDAEROCHAMBER PLUS* FLOW-VU* Antistatische voorzetkamer - Voor volwassenen - Mondstuk EUDAMEDAEROCHAMBER PLUS* FLOW-VU* Antistatische Inhalierhilfe - Jugend EUDAMEDAeroChamber Plus* Flow-Vu* Youth Mouthpiece 5+yrs Sample- Not For Sale EUDAMEDAEROCHAMBER PLUS* FLOW-VU* Cámara Antiestática de Retención con Válvula - Boquilla Câmara de Retenção Antiestática com Válvula - Bocal EUDAMEDAEROCHAMBER PLUS* FLOW-VU* Antistatische Inhalierhilfe – Jugend Unverkäufliches Muster EUDAMEDAEROCHAMBER PLUS* FLOW-VU* Adult Mouthpiece EUDAMEDAEROCHAMBER PLUS* FLOW-VU* Antistatische voorzetkamer - Mondstuk voor kinderen EUDAMEDAeroChamber* mini Anti-Static Holding Chamber EUDAMED
- Model / Reference
- 101502 EUDAMED108508/108508110035 EUDAMED108508/10850882050 EUDAMED108507/108507110070 EUDAMED108509 EUDAMED108509/108509119070 EUDAMED108504/108504115035 EUDAMED108504/108504117050 EUDAMED108504/10850482050 EUDAMED101503 EUDAMED108509/108509110060 EUDAMED108501 EUDAMED108501/10850184060 EUDAMED108509/108509115050 EUDAMED108509/108509115060 EUDAMED101504 EUDAMED108509/10850982050 EUDAMED108508/10850884035 EUDAMED108501/108501114060 EUDAMED108509/108509117050 EUDAMED108504/108504119050 EUDAMED108507/10850784070 EUDAMED108501 / 108501110060 EUDAMED108508/108508119050 EUDAMED108507/10850782080 EUDAMED108507/108507119090 EUDAMED108502/10850282080 EUDAMED108502/108502119090 EUDAMED108509/10850984060 EUDAMED108507/108507109070 EUDAMED108508/108508115050 EUDAMED87501 EUDAMED108502/108502117080 EUDAMED108508/108508115035 EUDAMED108502/108502115070 EUDAMED108502/108502115080 EUDAMED108504/108504114035 EUDAMED108501/108501119070 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00762860001374 EUDAMED00762860850897 EUDAMED00762860000032 EUDAMED00762860013506 EUDAMED00762860000667 EUDAMED00762860000100 EUDAMED00762860000223 EUDAMED00762860000049 EUDAMED00762860001367 EUDAMED00762860850996 EUDAMED00762860110304 EUDAMED00762860000186 EUDAMED00762860000124 EUDAMED00762860001381 EUDAMED00762860000063 EUDAMED00762860810303 EUDAMED00762860000346 EUDAMED00762860000247 EUDAMED00762860000643 EUDAMED00762860710306 EUDAMED00762860013537 EUDAMED00762860000636 EUDAMED00762860000018 EUDAMED00762860000612 EUDAMED00762860000025 EUDAMED00762860000629 EUDAMED00762860910300 EUDAMED00762860503786 EUDAMED00762860000155 EUDAMED00762860000803 EUDAMED00762860000209 EUDAMED00762860000094 EUDAMED00762860000087 EUDAMED00762860000148 EUDAMED00762860000339 EUDAMED00762860391062 EUDAMED00762860000650 EUDAMED
- Basic UDI-DI
- 762860VHC1NL EUDAMEDB-00762860000667 EUDAMEDB-00762860850996 EUDAMEDB-00762860110304 EUDAMEDB-00762860000186 EUDAMEDB-00762860000124 EUDAMEDB-00762860000063 EUDAMEDB-00762860000346 EUDAMEDB-00762860000247 EUDAMEDB-00762860013537 EUDAMEDB-00762860910300 EUDAMED762860MINI1EM EUDAMEDB-00762860000650 EUDAMED
- 510(k) Number
- K181649 FDA 510(k)
- FDA Product Code
- NVP FDA 510(k)
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5630 FDA 510(k)
- Regulation Number
- 868.5630 FDA 510(k)
- Market of Registration
- France EUDAMEDBelgium EUDAMEDPoland EUDAMEDGermany EUDAMEDItaly EUDAMEDAustria EUDAMEDNetherlands EUDAMEDPortugal EUDAMEDIreland EUDAMEDTürkiye EUDAMEDDenmark EUDAMEDSpain 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Pulmonary function analysis system, adult
AeroChamber Plus* by Trudell Medical International — Class I — FDA_510K, MDR, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181649 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 762860VHC1NL | Class I | Active |
| EUDAMED | European Union | CE/MDD | 762860VHC1NL | Class I | Active |
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Manufacturer
- Manufacturer
- Trudell Medical International
- EUDAMED SRN
- CA-MF-000009860
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (38)
- EUDAMED 5da753a3-b484-4384-9b78-47cf951ddb61 61 fields · synced Aug 5, 2026
- EUDAMED e105c10e-f825-4a0a-854a-b1f904c33fc0 61 fields · synced May 11, 2026
- EUDAMED 0303e8e6-f560-46a9-a172-d7b988dea62a 61 fields · synced May 11, 2026
- EUDAMED 505b66da-cadf-4ce7-88cd-46c86e4923bb 61 fields · synced May 16, 2026
- EUDAMED 4e55620c-5c44-4c1e-9af9-71985884c963 61 fields · synced May 16, 2026
- EUDAMED aac3cdb4-3db0-4cd3-9eeb-23a727eda0e6 61 fields · synced May 16, 2026
- EUDAMED c044e8ef-c4d2-4943-986f-9606a1cf57b5 61 fields · synced May 16, 2026
- EUDAMED 6c0fa2db-7aeb-4492-a427-e3a70b9add0b 61 fields · synced May 16, 2026
- EUDAMED aa47c2d3-fbe7-4aa7-96dc-e1180bcd903e 61 fields · synced May 16, 2026
- EUDAMED 0ac5b56c-ceb3-4946-aec6-61c356cb7c25 61 fields · synced May 16, 2026
- EUDAMED f235a43c-4bae-45a1-bc30-c8ef1772d945 61 fields · synced May 16, 2026
- EUDAMED 3ae7cd5f-971b-44ec-8285-3f10b0b2dd61 61 fields · synced May 16, 2026
- EUDAMED e9a22942-0031-4841-ae7c-48e174c6025b 61 fields · synced May 17, 2026
- EUDAMED d4938296-12e0-492d-a90a-9de00bd119d7 61 fields · synced May 17, 2026
- EUDAMED 78cf4dd4-9d4a-438a-85c4-f14cbe1b89ce 61 fields · synced May 17, 2026
- EUDAMED 3d443273-15e6-471b-8ebe-d14c04787375 61 fields · synced May 17, 2026
- EUDAMED 96b01995-082e-42ca-87f5-2e03a82f2e35 61 fields · synced May 17, 2026
- EUDAMED 819a1091-e148-48ed-8be1-249d27e13617 61 fields · synced May 17, 2026
- EUDAMED cb6a7138-38f0-4d2d-8f20-7c8170c422ee 61 fields · synced May 17, 2026
- EUDAMED bfe32ebe-ac5b-4276-b862-94861722e3c6 61 fields · synced May 18, 2026
- EUDAMED 37a24475-36c4-46d0-8681-4cbdcb18b824 61 fields · synced May 18, 2026
- EUDAMED 40cd8614-2acb-4c06-adec-b9699a0f32f1 61 fields · synced May 18, 2026
- EUDAMED c9618417-3867-42d0-93ae-b589ed5e0184 61 fields · synced May 18, 2026
- EUDAMED 36a7759c-6079-4a64-8624-602b81706ac5 61 fields · synced May 18, 2026
- EUDAMED e1e9db2d-708a-405c-857a-0e26abb3ce34 61 fields · synced May 18, 2026
- EUDAMED 420e390e-a4b0-46a1-a68e-5ed9bfbbedb1 61 fields · synced May 18, 2026
- EUDAMED 959de6d7-975f-4a6e-81eb-38697f6cd23b 61 fields · synced May 18, 2026
- EUDAMED c5f4efe9-c83a-462e-8bd2-2e7e95aeab19 61 fields · synced May 18, 2026
- EUDAMED 112981de-9c38-4d5a-a5c3-348672b718fa 61 fields · synced May 18, 2026
- EUDAMED 4e3c1882-eca0-4aed-9507-fd438b8805e7 61 fields · synced May 18, 2026
- EUDAMED 6d5c4661-e3a0-4cd2-ade1-c78a8b4a6273 61 fields · synced May 18, 2026
- EUDAMED 7aad5b57-6fd5-4315-a12d-5364bc8e858c 61 fields · synced May 18, 2026
- FDA 510(k) K181649 24 fields · synced May 18, 2026
- EUDAMED f311635d-958f-485f-8cc6-8b59798d0e38 61 fields · synced Jul 10, 2026
- EUDAMED 21d4a801-cedd-4965-a50f-3b0db1040ca9 61 fields · synced Jul 10, 2026
- EUDAMED 6cf00a71-bb84-40f3-bc5b-8e19f9ac74d7 61 fields · synced Jul 12, 2026
- EUDAMED 75f47eb4-0170-44f8-952b-82aebb8ecec6 61 fields · synced Jul 13, 2026
- EUDAMED f3e7332b-ac30-44ea-9af8-740ac6724c8c 61 fields · synced Jul 15, 2026