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Free-Breath

EUDAMED

Class IIa (EU MDR)

Ref 420011233 Model 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

by Taian Dalu Medical Instrument Co., Ltd.

Identity

Trade Name
Free-Breath EUDAMED
Device Name
Spacer for Aerosol EUDAMED
Model / Reference
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
420011233 EUDAMED

Identifiers

Primary DI / UDI-DI
06970701960146 EUDAMED
Basic UDI-DI
697070196420171004MZ EUDAMED
EMDN Code
R03010302 AEROSOL PORTABLE INHALERS 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

EUDAMED

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

Manufacturer
Taian Dalu Medical Instrument Co., Ltd.
EUDAMED SRN
CN-MF-000003009
Authorised Representative
Lotus NL B.V. NL-AR-000000121

Sources (1)

  • EUDAMED dcbccdce-e02e-45a9-a825-13bb8c96ffb3 61 fields · synced Jun 18, 2026