sanity

EUDAMED

Class IIa (EU MDR)

Ref 420241012Model 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: sanity 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
420241012 EUDAMED

Identifiers

Primary DI / UDI-DI: 06970701966919 EUDAMED
Basic UDI-DI: 697070196420171004MZ EUDAMED
Direct Marketing DI: 06970701966919 EUDAMED
EMDN Code: R03010302 AEROSOL PORTABLE INHALERS EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Poland EUDAMED

Clinical & Handling

Sterile

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

sanity 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	697070196420171004MZ	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 (1)

EUDAMED 1443eea5-6a43-4441-8d1d-78d2f70766d0 61 fields · synced Oct 6, 2026