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LF1 Nebulizer w/Valve T Kit, 22F
EUDAMEDClass IIa (EU MDR)
Ref AD0023Model (E) Aerosol TherapyRef AD0016
Identity
- Trade Name
- LF1 Nebulizer w/Valve T Kit, 22F EUDAMEDLF1 Nebulizer EUDAMED
- Device Name
- Nebulizer Kit EUDAMEDNebulizer EUDAMED
- Model / Reference
- (E) Aerosol Therapy EUDAMEDAD0023 EUDAMEDAD0016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810119385 EUDAMED44710810118010 EUDAMED
- Basic UDI-DI
- 471081008NNED8B EUDAMED471081008NNE279 EUDAMED
- EMDN Code
- R03010304 AEROSOL THERAPY KITS 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
LF1 Nebulizer w/Valve T Kit, 22F by GaleMed Corporation — 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 | 471081008NNED8B | Class IIa | Active |
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Manufacturer
- Manufacturer
- GaleMed Corporation
- EUDAMED SRN
- TW-MF-000022411
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 3c018527-cbbd-4410-b03f-b7c38da99697 61 fields · synced Jul 12, 2026
- EUDAMED 04f139a8-2cc1-406d-a55b-465255708457 61 fields · synced May 18, 2026