Identity
- Trade Name
- Newborn Masks EUDAMED
- Device Name
- Newborn Mask EUDAMED
- Model / Reference
- Newborn Mask EUDAMEDLGH-846156 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07045432092431 EUDAMED
- Basic UDI-DI
- 0704543209949TE EUDAMED
- Direct Marketing DI
- 07045432092431 EUDAMED
- EMDN Code
- R03010199 VENTILATION MASKS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Norway 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
Newborn Masks by Laerdal Medical AS — 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 | 0704543209949TE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Laerdal Medical AS
- EUDAMED SRN
- NO-MF-000000012
Sources (1)
- EUDAMED 3761b145-baa7-47b0-9424-af403fcd85e6 61 fields · synced Jun 19, 2026