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AVRON BreathCheck
EUDAMEDClass IIa (EU MDR)
Ref DL-08BModel 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
Identity
- Trade Name
- AVRON BreathCheck 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 EUDAMEDDL-08B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970701961020 EUDAMED
- Basic UDI-DI
- 697070196420171004MZ EUDAMED
- EMDN Code
- R03010302 AEROSOL PORTABLE INHALERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Greece 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
AVRON BreathCheck 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 18172d21-0d92-40ac-a03b-06dcb5d84bf7 61 fields · synced Jun 18, 2026