Data / Medical devices / Norway / Laerdal Medical A/S
Laerdal Medical A/S: FDA-registered device maker in STAVANGER Rogaland, Norway, 7 510(k) clearances
Laerdal Medical A/S is registered with the FDA (registration 9610483) in STAVANGER Rogaland, Norway. It lists 9 device types. The FDA files 7 510(k) clearances under its listings, the newest dated November 24, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9610483
- FEI number
- 3002807435
- Address
- Seehusens gate 1, STAVANGER Rogaland, Norway, 4024
- Owner or operator
- LAERDAL MEDICAL A/S (9038993)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- February 2, 2005
- Registered through
- 2026
- Brand names listed
- American Red Cross Face Shield, BaXstrap, CPRmeter 2, Laerdal Face Shield, Laerdal Face Shield Key Ring, Laerdal Silicone Mask, NeoNatalie Complete Kit, NeoNatalie Resuscitator and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aid, Cardiopulmonary Resuscitation | LIX | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Attachment, Breathing, Positive End Expiratory Pressure | BYE | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Device, Prosthesis Alignment | IQO | 1 | Specification developer | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Specification developer | accessdata.fda.gov |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | CAP | 2 | Specification developer | accessdata.fda.gov |
| Orthosis, Truncal/Orthosis, Limb | MRI | 1 | Specification developer | accessdata.fda.gov |
| Stretcher, Hand-Carried | FPP | 1 | Specification developer | accessdata.fda.gov |
| Stretcher, Patient Restraint | NZD | 1 | Exporter to the US | accessdata.fda.gov |
| Ventilator, Emergency, Manual (Resuscitator) | BTM | 2 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 24, 2025 | K251631 | The BAG manual resuscitator and accessories | BTM | Substantially Equivalent | Laerdal Medical AS | accessdata.fda.gov |
| December 17, 2018 | K183348 | Reusable Silicone Cover CPRmeter 2 | LIX | Substantially Equivalent | Laerdal Medical AS | accessdata.fda.gov |
| March 23, 2018 | K173886 | CPRmeter 2 CPR Feedback Device | LIX | Substantially Equivalent | Laerdal Medical AS | accessdata.fda.gov |
| January 15, 2015 | K132172 | NEONATALIE RESUSCITATOR | BTM | Substantially Equivalent | Laerdal Medical A/S | accessdata.fda.gov |
| June 26, 2001 | K003927 | Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02 | BTM | Substantially Equivalent | Cheen Houng Ent. Co. , Ltd. | accessdata.fda.gov |
| July 14, 1998 | K981415 | 0-20 CM H20 PEEP VALVE | BYE | Substantially Equivalent | Cheen Houng Ent. Co. , Ltd. | accessdata.fda.gov |
| March 4, 1988 | K880450 | RESUSCI PATIENT FACE SHIELD | BTM | Substantially Equivalent | Laerdal Medical Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Orthosis, Truncal/Orthosis, Limb
- All makers of Aid, Cardiopulmonary Resuscitation
- All makers of Ventilator, Emergency, Manual (Resuscitator)
- All makers of Mask, Oxygen
- All makers of Stretcher, Patient Restraint
- All makers of Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Updated November 24, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.