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Laerdal Disposable Mask
EUDAMEDClass IIa (EU MDR)
Ref 845260Model Laerdal Disp. Mask #4, w/inflation port, pkg 20
Identity
- Trade Name
- Laerdal Disposable Mask EUDAMED
- Device Name
- The BAG II Disposable Resuscitator EUDAMED
- Model / Reference
- Laerdal Disp. Mask #4, w/inflation port, pkg 20 EUDAMED845260 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07045432084122 EUDAMED
- Basic UDI-DI
- B-07045432084122 EUDAMED
- EMDN Code
- R030180 RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Laerdal Disposable Mask by Laerdal Medical AS — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07045432084122 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Laerdal Medical AS
- EUDAMED SRN
- NO-MF-000000012
Sources (1)
- EUDAMED ccbe9a61-cffc-4406-88b5-12c214764574 61 fields · synced Jun 18, 2026