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Free-Breath
EUDAMEDClass IIa (EU MDR)
Ref MDN 1201Model DL-03C、DL-03、DL-03A、DL-03B、 DL-14、DL-15、DL-20、Soldist、Aeromate PlusModel DL-04、DL-11
Identity
- Trade Name
- Free-Breath 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 EUDAMEDMDN 1201 EUDAMEDDL-04、DL-11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970701960771 EUDAMED06970701960856 EUDAMED
- Basic UDI-DI
- 697070196420191012NN EUDAMED697070196420041003LH 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
| 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 (2)
- EUDAMED 5bd0af70-d5b6-46a2-8366-605dd6a7f916 61 fields · synced Oct 6, 2026
- EUDAMED 357830d5-403d-4d60-8d13-330edf4c761d 61 fields · synced May 19, 2026