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Free-Breath
EUDAMEDClass IIa (EU MDR)
Ref MDN 1201Model Turbo、La petiteModel DL-03C、DL-03、DL-03A、DL-03B、 DL-14、DL-15、DL-20、Soldist、Aeromate PlusModel DL-01D/DL-01/DL-01A/DL-01B/DL-01C/DL-07/DL-08/DL-08A/DL-08B/DL-08C/DL-08D/DL-09/DL-10/DL-13/DL-16/DL-17/DL-18/DL-19/AS175/Intec/aeolos/Maclife/Esencia/Aeroget Farmasol/Salbomatic/Instaspacer/Easychamber/Transpacer G/Transpacer VM/Universal-ChamberModel DL-DN-L、DL-DN-M、DL-DN-S、DL-DN-K、DL-DN-CCModel DL-02、DL-02A、DL-02B、Aerospacer PlusModel DL-DN-CL、DL-DN-CM、DL-DN-CS、DL-DN-CK、DL-DN-CCCRef MDA 0307Model DL-C02Model La grandeModel DL-06C、DL-06、DL-06A
Identity
- Trade Name
- Free-Breath EUDAMED
- Device Name
- Spacer for Aerosol EUDAMEDDisposable Nebulizers EUDAMEDCompressor Nebulizer EUDAMED
- Model / Reference
- Turbo、La petite EUDAMEDMDN 1201 EUDAMEDDL-03C、DL-03、DL-03A、DL-03B、 DL-14、DL-15、DL-20、Soldist、Aeromate Plus EUDAMEDDL-01D/DL-01/DL-01A/DL-01B/DL-01C/DL-07/DL-08/DL-08A/DL-08B/DL-08C/DL-08D/DL-09/DL-10/DL-13/DL-16/DL-17/DL-18/DL-19/AS175/Intec/aeolos/Maclife/Esencia/Aeroget Farmasol/Salbomatic/Instaspacer/Easychamber/Transpacer G/Transpacer VM/Universal-Chamber EUDAMEDDL-DN-L、DL-DN-M、DL-DN-S、DL-DN-K、DL-DN-CC EUDAMEDDL-02、DL-02A、DL-02B、Aerospacer Plus EUDAMEDDL-DN-CL、DL-DN-CM、DL-DN-CS、DL-DN-CK、DL-DN-CCC EUDAMEDDL-C02 EUDAMEDMDA 0307 EUDAMEDLa grande EUDAMEDDL-06C、DL-06、DL-06A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970701966308 EUDAMED06970701967718 EUDAMED06970701967022 EUDAMED06970701963888 EUDAMED06970701963703 EUDAMED06970701968142 EUDAMED06970701968326 EUDAMED06970701966636 EUDAMED06970701968234 EUDAMED06970701968739 EUDAMED06970701967336 EUDAMED06970701963895 EUDAMED06970701964922 EUDAMED06970701969026 EUDAMED06970701966216 EUDAMED06970701967619 EUDAMED06970701968814 EUDAMED06970701964106 EUDAMED06970701960788 EUDAMED06970701966087 EUDAMED06970701966117 EUDAMED06970701966742 EUDAMED06970701966834 EUDAMED06970701960474 EUDAMED06970701967435 EUDAMED
- Basic UDI-DI
- 697070196420091006NE EUDAMED697070196420191012NN EUDAMED697070196420171004MZ EUDAMED697070196400061011KY EUDAMED697070196420021044L9 EUDAMED697070196400061014L6 EUDAMED697070196450021006MS EUDAMED697070196420111003KV EUDAMED697070196420061001M3 EUDAMED
- EMDN Code
- R03010302 AEROSOL PORTABLE INHALERS EUDAMEDR03010301 AEROSOL THERAPY MASKS EUDAMEDR060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
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
EUDAMEDEUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Free-Breath by Taian Dalu Medical Instrument Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697070196420091006NE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Taian Dalu Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000003009
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (25)
- EUDAMED 7feb500a-f818-4eda-b833-a85f41cfe849 61 fields · synced Oct 6, 2026
- EUDAMED a70b0e2c-b3fa-4daa-99ef-97bb60913df4 61 fields · synced May 16, 2026
- EUDAMED 62ac7b9e-31cc-4fda-81ec-eec6485684d4 61 fields · synced May 16, 2026
- EUDAMED a6617186-9338-4e1c-83ff-bf0d04c7606b 61 fields · synced May 16, 2026
- EUDAMED ef76a071-e955-4ef6-b063-037d76067357 61 fields · synced May 17, 2026
- EUDAMED 9cfb38ce-f84b-45fd-82a1-a0268e719487 61 fields · synced May 17, 2026
- EUDAMED dde83dde-0c4c-4bd0-8f64-41397f9f3ad8 61 fields · synced May 17, 2026
- EUDAMED 28fd6c20-fd40-4ccb-b797-ed81519c3303 61 fields · synced May 17, 2026
- EUDAMED 5c2c8619-8727-44fa-936f-4f9761c31264 61 fields · synced May 17, 2026
- EUDAMED 794ca103-e76b-4a10-832d-824f7c81d6a7 61 fields · synced May 17, 2026
- EUDAMED 0ffb3b7f-daa1-4626-96ff-1ce69d926c92 61 fields · synced May 18, 2026
- EUDAMED c298b186-123a-4e40-b7ad-f49affaafcdf 61 fields · synced May 18, 2026
- EUDAMED 88aa917f-c000-4498-a3dc-bd7766c5f854 61 fields · synced May 18, 2026
- EUDAMED 0b61ba60-5769-488f-9e06-2149cf44ec78 61 fields · synced May 18, 2026
- EUDAMED 5e9a89dd-01cd-414e-83d3-a446a62485d9 61 fields · synced May 18, 2026
- EUDAMED 7ff1a759-cc9f-4977-808f-c7d6099a2a58 61 fields · synced May 18, 2026
- EUDAMED 6f8d774e-7513-4fae-983b-816020fa30c2 61 fields · synced May 18, 2026
- EUDAMED 15a6f124-aa1c-41f2-a8bf-47d937ce0e18 61 fields · synced May 19, 2026
- EUDAMED 93389bfe-4323-4fcc-bf72-68340a923022 61 fields · synced May 19, 2026
- EUDAMED 55f50191-d6c0-48ee-aab7-a6d3d76b567a 61 fields · synced May 19, 2026
- EUDAMED 01d1cbae-e1ee-42c4-9578-c6530638ad54 61 fields · synced May 19, 2026
- EUDAMED 81c6fa74-8c44-4eea-b709-f58ca53b4b6b 61 fields · synced May 19, 2026
- EUDAMED fe57aee0-1e2e-4e20-adb8-a68825971e2b 61 fields · synced May 19, 2026
- EUDAMED 1203e579-6379-4501-b8be-34da9c46c53f 61 fields · synced May 19, 2026
- EUDAMED 14134ad5-048b-41af-a435-6ff17ec859dd 61 fields · synced May 19, 2026