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Free-Breath

EUDAMED

Class 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

by Taian Dalu Medical Instrument Co., Ltd.

Identity

Trade Name
Free-Breath EUDAMED
Device Name
Spacer for Aerosol EUDAMED
Disposable Nebulizers EUDAMED
Compressor Nebulizer EUDAMED
Model / Reference
Turbo、La petite EUDAMED
MDN 1201 EUDAMED
DL-03C、DL-03、DL-03A、DL-03B、 DL-14、DL-15、DL-20、Soldist、Aeromate Plus EUDAMED
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-Chamber EUDAMED
DL-DN-L、DL-DN-M、DL-DN-S、DL-DN-K、DL-DN-CC EUDAMED
DL-02、DL-02A、DL-02B、Aerospacer Plus EUDAMED
DL-DN-CL、DL-DN-CM、DL-DN-CS、DL-DN-CK、DL-DN-CCC EUDAMED
DL-C02 EUDAMED
MDA 0307 EUDAMED
La grande EUDAMED
DL-06C、DL-06、DL-06A EUDAMED

Identifiers

Primary DI / UDI-DI
06970701966308 EUDAMED
06970701967718 EUDAMED
06970701967022 EUDAMED
06970701963888 EUDAMED
06970701963703 EUDAMED
06970701968142 EUDAMED
06970701968326 EUDAMED
06970701966636 EUDAMED
06970701968234 EUDAMED
06970701968739 EUDAMED
06970701967336 EUDAMED
06970701963895 EUDAMED
06970701964922 EUDAMED
06970701969026 EUDAMED
06970701966216 EUDAMED
06970701967619 EUDAMED
06970701968814 EUDAMED
06970701964106 EUDAMED
06970701960788 EUDAMED
06970701966087 EUDAMED
06970701966117 EUDAMED
06970701966742 EUDAMED
06970701966834 EUDAMED
06970701960474 EUDAMED
06970701967435 EUDAMED
Basic UDI-DI
697070196420091006NE EUDAMED
697070196420191012NN EUDAMED
697070196420171004MZ EUDAMED
697070196400061011KY EUDAMED
697070196420021044L9 EUDAMED
697070196400061014L6 EUDAMED
697070196450021006MS EUDAMED
697070196420111003KV EUDAMED
697070196420061001M3 EUDAMED
EMDN Code
R03010302 AEROSOL PORTABLE INHALERS EUDAMED
R03010301 AEROSOL THERAPY MASKS EUDAMED
R060101 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

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Manufacturer

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