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Laerdal Pocket Mask
EUDAMEDClass I (EU MDR)
Ref 82004102Model Pocket Mask Ref 83004002Model Pocket Mask with Oxygen Ref 82004002Ref 82004000Ref 83001107Ref 82004207Ref 839911Ref 829952Ref 82004107Ref 82000602Model Laerdal Pocket MaskRef 820023Ref 83001104
Identity
- Trade Name
- Laerdal Pocket Mask EUDAMED
- Device Name
- Laerdal Pocket Mask EUDAMED
- Model / Reference
- Pocket Mask EUDAMED82004102 EUDAMEDPocket Mask with Oxygen EUDAMED83004002 EUDAMED82004002 EUDAMED82004000 EUDAMED83001107 EUDAMED82004207 EUDAMED839911 EUDAMED829952 EUDAMED82004107 EUDAMEDLaerdal Pocket Mask EUDAMED82000602 EUDAMED820023 EUDAMED83001104 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07045430043848 EUDAMED07045430044425 EUDAMED07045430043749 EUDAMED07045430043732 EUDAMED07045430044272 EUDAMED07045430008014 EUDAMED07045430011830 EUDAMED07045430011731 EUDAMED07045430043862 EUDAMED07045430043558 EUDAMED07045432006247 EUDAMED07045430044265 EUDAMED
- Basic UDI-DI
- 0704543209950SX EUDAMED0704543209951SZ EUDAMED0704543209939TB EUDAMED
- Direct Marketing DI
- 07045430043558 EUDAMED
- EMDN Code
- R03010199 VENTILATION MASKS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMED
- Market of Registration
- Norway EUDAMED
- Medical Purpose
- The Laerdal Pocket Mask is designed for mouth-to-mask ventilation of a non-breathing adult, child or infant as a barrier between the rescuer and patient. For use on an infant, the mask may be turned 180° to achieve a better seal. EUDAMEDThe Pocket Mask with Oxygen Inlet is designed for mouth-to-mask ventilation of a non-breathing adult as a barrier between the rescuer and patient. The Pocket Mask with Oxygen Inlet can be connected to an external Oxygen source 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 Pocket Mask by Laerdal Medical AS — Class I — 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 | 0704543209950SX | Class I | Active |
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Manufacturer
- Manufacturer
- Laerdal Medical AS
- EUDAMED SRN
- NO-PR-000002650
Sources (12)
- EUDAMED 47e5b47f-bed0-4404-8f66-bdf66edd7745 61 fields · synced Jul 22, 2026
- EUDAMED b17074d5-5e7f-4249-86da-ba6c751ffc48 61 fields · synced May 16, 2026
- EUDAMED 22dddc33-7461-4dae-8681-a9c44b0c857a 61 fields · synced May 16, 2026
- EUDAMED 705b45bd-205d-4e02-a286-b68304c82249 61 fields · synced May 16, 2026
- EUDAMED 13d2c7c4-fa8f-47a0-a3cd-47f33c2bab38 61 fields · synced May 17, 2026
- EUDAMED a8b9fba8-1107-4ed7-9cf4-fda7cddcb38e 61 fields · synced May 17, 2026
- EUDAMED d71eee20-9e48-4792-862b-d47cb8c58838 61 fields · synced May 17, 2026
- EUDAMED 1018b662-2f3b-4898-9d4b-1ac4f88ee660 61 fields · synced May 17, 2026
- EUDAMED cd6c7623-de5e-4308-bffe-7d103b9c01e4 61 fields · synced May 17, 2026
- EUDAMED 613d30f2-0521-42ff-b57f-58970a028e19 61 fields · synced May 17, 2026
- EUDAMED cd8d6f62-d654-4f3b-aec3-1b698ea8b9bf 61 fields · synced May 18, 2026
- EUDAMED 2dec8bfd-c5e7-4239-b3ad-18077d5be428 61 fields · synced May 18, 2026