Identity
- Trade Name
- lifesense EUDAMED
- Device Name
- Spacer for Aerosol EUDAMED
- Model / Reference
- DL-12、DL-27 EUDAMEDMD1013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970701961976 EUDAMED
- Basic UDI-DI
- 697070196420291003P2 EUDAMED
- EMDN Code
- R03010301 AEROSOL THERAPY MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland 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
lifesense 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 | 697070196420291003P2 | 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 e8230235-1db9-4943-84fd-39b706150b34 61 fields · synced Jun 19, 2026