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Zeffiro

EUDAMED

Class IIa (EU MDR)

Ref SPC04Model 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
Zeffiro 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
SPC04 EUDAMED

Identifiers

Primary DI / UDI-DI
06970701960283 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

Zeffiro 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 0a8f8d93-a8fa-4310-89c2-f6e3a85a56aa 61 fields · synced Oct 6, 2026