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Laerdal Silicone Masks
EUDAMEDClass IIa (EU MDR)
Ref 875200Model Laerdal Silicone Mask
Identity
- Trade Name
- Laerdal Silicone Masks EUDAMED
- Device Name
- Laerdal Silicone Mask EUDAMED
- Model / Reference
- Laerdal Silicone Mask EUDAMED875200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07045430012660 EUDAMED
- Basic UDI-DI
- 0704543209946T8 EUDAMED
- Direct Marketing DI
- 07045430012660 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
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
Laerdal Silicone 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 | 0704543209946T8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Laerdal Medical AS
- EUDAMED SRN
- NO-MF-000000012
Sources (1)
- EUDAMED 66818734-61ef-479a-948b-e536313f1dc1 61 fields · synced May 22, 2026