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Atomisor Smartchamber
EUDAMEDClass IIa (EU MDR)
Ref ASCNModel DL-03C、DL-03、DL-03A、DL-03B、 DL-14、DL-15、DL-20、Soldist、Aeromate PlusRef ASCARef ASCE
Identity
- Trade Name
- ATOMISOR SMARTCHAMBER EUDAMEDATOMISOR SMARTCHAMBER EUDAMED
- Device Name
- Spacer for Aerosol EUDAMED
- Model / Reference
- DL-03C、DL-03、DL-03A、DL-03B、 DL-14、DL-15、DL-20、Soldist、Aeromate Plus EUDAMEDASCN EUDAMEDASCA EUDAMEDASCE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970701960559 EUDAMED06970701960573 EUDAMED06970701960566 EUDAMED
- Basic UDI-DI
- 697070196420191012NN EUDAMED
- EMDN Code
- R03010302 AEROSOL PORTABLE INHALERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Atomisor Smartchamber 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 | 697070196420191012NN | 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 (3)
- EUDAMED 68381a89-3dcc-4412-9402-5f6ebbb7d55a 61 fields · synced Oct 6, 2026
- EUDAMED ed945e33-af59-4705-887a-beaec636b16f 61 fields · synced May 18, 2026
- EUDAMED 063bfe61-08a4-4fb8-aaf8-7e9e6110420e 61 fields · synced May 19, 2026