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Spacer for Aerosol
EUDAMEDClass IIa (EU MDR)
Ref ICA-12Model Spacer for Aerosol
Identity
- Device Name
- Spacer for Aerosol EUDAMED
- Model / Reference
- Spacer for Aerosol EUDAMEDICA-12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970240895909 EUDAMED
- Basic UDI-DI
- 697024089SAY9 EUDAMED
- Direct Marketing DI
- 06970240895909 EUDAMED
- EMDN Code
- R0699 NEBULISATION AND HUMIDIFICATION SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Estonia 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
Spacer for Aerosol by Ningbo Luke Medical Devices 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 | 697024089SAY9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ningbo Luke Medical Devices Co., LTD
- EUDAMED SRN
- CN-MF-000011732
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 24b1d71d-d076-470e-8c1c-a66a73745b67 61 fields · synced Oct 7, 2026