← Back to catalogue
The BAG Adult Mask 4
EUDAMEDClass IIa (EU MDR)
Ref 847340401Model The BAG and The BAG Mask
Identity
- Trade Name
- The BAG Adult Mask 4 EUDAMED
- Device Name
- The BAG and The BAG Mask EUDAMED
- Model / Reference
- The BAG and The BAG Mask EUDAMED847340401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07045432119411 EUDAMED
- Basic UDI-DI
- 0704543209970T5 EUDAMED
- EMDN Code
- R03010199,R03020201 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Laerdal The BAG is a non-sterile single use self-inflating manual resuscitator. The BAG is indicated for patients requiring total or intermittent ventilatory support. Ventilation is possible with or without supplemental oxygen. The BAG Mask is a non-sterile single use face mask for use with Laerdal The BAG resuscitator. The BAG Mask is indicated for use with patients requiring ventilation. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
The BAG Adult Mask 4 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 | 0704543209970T5 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Laerdal Medical AS
- EUDAMED SRN
- NO-PR-000002650
Sources (1)
- EUDAMED f6e11374-ebe4-49a0-9601-2cb82dc3bece 61 fields · synced Jul 11, 2026