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Laerdal Silicone Resuscitator
EUDAMEDClass IIa (EU MDR)
Ref 85005157Model LSR Complete w/Masks
Identity
- Trade Name
- Laerdal Silicone Resuscitator EUDAMED
- Device Name
- Laerdal Silicone Resuscitator EUDAMED
- Model / Reference
- LSR Complete w/Masks EUDAMED85005157 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07045432101522 EUDAMED
- Basic UDI-DI
- 0704543209968TJ EUDAMED
- EMDN Code
- R03020199 VENTILATION BALLOONS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- The Laerdal Silicone Resuscitator (LSR) is intended for patients requiring total or intermittent ventilatory support. Ventilation is possible with or without supplemental oxygen. The Laerdal Silicone Resuscitator is available in three sizes: • The Adult model is intended for patients over 25 kg (44 lb). • The Paediatric model is intended for patients from 2.5 kg (5.5 lb) to 25 kg (44 lb). • The Preterm model is intended for patients below 2.5 kg (5.5 lb). EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Laerdal Silicone Resuscitator 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 | 0704543209968TJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Laerdal Medical AS
- EUDAMED SRN
- NO-PR-000002650
Sources (1)
- EUDAMED 456b888c-b49f-427a-a63f-94f013619912 61 fields · synced Jun 18, 2026