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NeoNatalie Resuscitator
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 846040Model NeoNatalie ResuscitatorRef LGH-846040
Identity
- Trade Name
- NeoNatalie Resuscitator EUDAMEDNeoNatalie Resuscitator EUDAMED
- Device Name
- NeoNatalie Resuscitator EUDAMED
- Model / Reference
- NeoNatalie Resuscitator EUDAMED846040 EUDAMEDLGH-846040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07045432051209 EUDAMED07045432092004 EUDAMED
- Basic UDI-DI
- 0704543209947TA EUDAMED
- Direct Marketing DI
- 07045432051209 EUDAMED07045432092004 EUDAMED
- EMDN Code
- R03020199 VENTILATION BALLOONS - 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
NeoNatalie Resuscitator by Laerdal Medical AS — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132172 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0704543209947TA | Class IIa | Active |
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Manufacturer
- Manufacturer
- Laerdal Medical AS
- EUDAMED SRN
- NO-MF-000000012
Sources (3)
- EUDAMED 175a77c4-44b0-4969-b147-4b6463c59a20 61 fields · synced Oct 6, 2026
- EUDAMED 65951bda-dce6-4e2f-a883-24d8c32d32fa 61 fields · synced May 18, 2026
- FDA 510(k) K132172 1 fields · synced May 18, 2026