Laerdal Medical (Suzhou) Co., Ltd.
Registered establishment in 215009 Suzhou Jiangsu Province, China. 12 device types.
Laerdal Medical (Suzhou) Co., Ltd. is a repacker / relabeller holding a current FDA establishment registration. The registration covers Mask, Oxygen, Orthosis, Cervical and 10 other device types. Its earliest product listing with the FDA dates from 2005.
Registration
| Registered name | LAERDAL MEDICAL (SUZHOU) CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3004993040 |
| FEI number | 3004993040 |
| Establishment type | Repacker / relabeller, Manufacturer |
Chinese Registration
| Chinese legal name | 挪度医疗器械（苏州）有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | 215009 Suzhou Jiangsu Province |
|---|---|
| Address | NO.19 BLDG., HUOJU RD. |
| Postal code | — |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Apparatus, Suction, Ward Use, Portable, Ac-Powered | Class 2 | Laerdal Compact Suction Unit 4 (LCSU 4) | 2012 | 5 |
| Attachment, Breathing, Positive End Expiratory Pressure | Class 2 | The BAG PEEP Valve, The BAG, The BAG Manometer | 2025 | 9 |
| Device, Fixation, Tracheal Tube | Class 1 | Thomas Tube Holder Pediatric, Thomas Tube Holder Adult, Thomas Select Tube Holder – Adult, Thomas Endotracheal Tube Holder | 2005 | 46 |
| Mask, Oxygen | Class 1 | Laerdal Silicone Mask, Newborn Mask Snap Design, The BAG Mask | 2018 | 126 |
| Mask, Oxygen, Non-Rebreathing | Class 1 | Laerdal Pocket Mask, American Red Cross Pocket Mask | 2006 | 72 |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | Class 2 | The BAG PEEP Valve, The BAG, The BAG Manometer | 2025 | 7 |
| Orthosis, Cervical | Class 1 | Stifneck, Stifneck Pedi-Select, Stifneck Select | 2005 | 114 |
| Orthosis, Truncal/Orthosis, Limb | Class 1 | Sta-Blocks, SpeedBlocks | 2005 | 68 |
| Pump, Portable, Aspiration (Manual Or Powered) | Class 2 | V-VAC Manual Suction Unit, Laerdal Suction Unit (LSU) | 2008 | 14 |
| Syringe, Irrigating (Non Dental) | Class 1 | Penguin Suction Device, NeoNatalie Suction, Penguin Newborn Suction, Penguin Irrigating Syringe | 2010 | 110 |
| Valve, Non-Rebreathing | Class 2 | Laerdal Paediatric Pocket Mask, Laerdal Pocket Mask, American Red Cross Pocket Mask | 2006 | 19 |
| Ventilator, Emergency, Manual (Resuscitator) | Class 2 | The BAG PEEP Valve, The BAG, The BAG Manometer, Laerdal Silicone Resuscitator (LSR), American Red Cross Face Shield, Laerdal Face Shield Key Ring and 4 more | 2008 | 8 |
Clearances
No clearance names Laerdal Medical (Suzhou) Co., Ltd. as applicant. 10 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K251631 | 2025-11-24 | BTM | Traditional | Laerdal Medical Corp. |
| K132172 | 2015-01-15 | BTM | Abbreviated | Laerdal Medical A/S |
| K120065 | 2012-04-03 | JCX | Traditional | Plaxtron Industrial (M) SDN. BHD. |
| K023805 | 2003-02-11 | CBP | Special | Laerdal Medical A/S |
| K993668 | 1999-12-20 | BTA | Traditional | Laerdal Medical A/S |
| K933048 | 1993-12-02 | KGB | Traditional | Laerdal Medical Corp. |
| K880450 | 1988-03-04 | BTM | Traditional | Laerdal Medical Corp. |
| K862875 | 1986-11-03 | BTA | Traditional | Laerdal California, Inc. |
| K861401 | 1986-05-21 | CBP | Traditional | Laerdal Medical Corp. |
| K832990 | 1983-11-07 | IQK | Traditional | Laerdal California, Inc. |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-12-18 | Class II | Device Design | Component failures may cause the unit to lose all suction. Users will need to obtain alternate suction devices or methods, leading to a delay in treatment and, in worst case scenario, potential suffocation if alternative suction or ventilat | 5035 | 2023-12-11 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2003 |
|---|---|
| Main products | Basic life support equipment, Advanced life support, Simulation training materials, Nursing equipment, Airway management |
| Export markets | Global |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.