FDA Registration
Active
🇳🇴 Norway
LAERDAL MEDICAL A/S
Reg #: 9610483
·
FEI: 3002807435
·
Expires 2026
Products
9
Proprietary Names
22
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- LAERDAL MEDICAL A/S
- Registration Number
- 9610483
- FEI Number
- 3002807435
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Tanke Svilandsgate 30
- City
- STAVANGER Rogaland
- Country
- NO
Regulatory Submissions
- 510(k) Number
- K132172
Owner / Operator
- Firm Name
- LAERDAL MEDICAL A/S
- Operator Number
- 9038993
- Address
- Tanke Svilandsgate 30, --
- City
- Stavanger
- State
- Rogaland
- Postal Code
- 4007
- Country
- NO
US Agent
- Business Name
- Laerdal Medical Corporation
- Contact Name
- Carl Narvesen
- Address
- 167 MYERS CORNERS RD., --
- City
- Wappingers Falls
- State
- NY
- ZIP
- 12590
- Country
- US
- [email protected]
- Phone
- 845 2455201
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ventilator, Emergency, Manual (Resuscitator) | BTM | Class 2 | Anesthesiology | No | 2015-04-15 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2018-03-20 |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | CAP | Class 2 | Anesthesiology | No | 2025-12-22 |
| Attachment, Breathing, Positive End Expiratory Pressure | BYE | Class 2 | Anesthesiology | No | 2025-12-22 |
| Stretcher, Hand-Carried | FPP | Class 1 | General Hospital | No | 2005-02-02 |
| Device, Prosthesis Alignment | IQO | Class 1 | Physical Medicine | No | 2005-02-02 |
| Aid, Cardiopulmonary Resuscitation | LIX | Class 2 | Cardiovascular | No | 2019-01-02 |
| Orthosis, Truncal/Orthosis, Limb | MRI | Class 1 | Physical Medicine | No | 2005-02-02 |
| Stretcher, Patient Restraint | NZD | Class 1 | General Hospital | No | 2022-04-07 |
Proprietary Names
NeoNatalie Resuscitator
NeoNatalie Complete Kit
Newborn Mask Snap Design
Laerdal Silicone Mask
The BAG Mask
The BAG PEEP Valve
The BAG
The BAG Manometer
Laerdal Face Shield
Laerdal Face Shield Key Ring
Resusci Patient Face Shield
American Red Cross Face Shield
BaXstrap
PadPack Alignment Pads
The BAG II Disposable Resuscitator
CPRmeter 2
Sta-Blocks
SpeedBlocks
STX 494 2 PC BELT W/METAL, ST00494B
ROCK STRAPS - IMMOBILIZATION BELTS ADULT BACKBOARD, ST02035A
STX 598 RESTRAINT BELT 2 PCS, ST00598A
ROCK STRAPS - IMMOBILIZATION BELTS ADULT BACKBOARD, ST02035L
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device