SunMed
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000009164
- Devices
- 1,279
- Registrations
- EUDAMED
- FDA recalls
- 15
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA recalls
- Authorised rep.
- Medical Technology Promedt Consulting GmbHDE
What SunMed makes
SunMed manufactures reusable and single-use laryngoscope blades and handles, endotracheal tubes, airway devices (oropharyngeal and nasopharyngeal), and an endotracheal tube holder. The company also produces a mechanical external stethoscope for clinical use.
The company’s products are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. SunMed is based in the United States.
Catalogue
Search and filter all 1,279 devicesShowing 1-50 of 1,279
Company details
- EUDAMED SRN
- US-MF-000009164
- EUDAMED status
- Active
- EUDAMED registered name
- SunMed, LLC
- Registered address
- 2710 Northridge Dr. NW, Suite A, 49544, Grand Rapids, United States
- Website
- info@sun-med.com
- linkedin.com/company/myairlife
- Phone
- +1-269-873-0502
- PRRC contact
- Robert Yamashita
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 29 May 2028
BSI Group The Netherlands B.V. 2797 1 certificate
- MDR 761256 Active
Quality management system EU MDR
- Issued
- 26 Aug 2026
- Expires
- 29 May 2028
- Reason
- Add device or group
FDA recalls
FDA recall records list 15 recalls initiated by SunMed, the earliest on 2007-04-27 and the most recent on 2018-05-24. By recorded status: 15 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 14
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2018
- 24 May 2018 Z-2145-2018 Class II Terminated There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
- 24 May 2018 Z-2146-2018 Class II Terminated There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
- 24 May 2018 Z-2147-2018 Class II Terminated There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
- 24 May 2018 Z-2148-2018 Class II Terminated There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
- 24 May 2018 Z-2149-2018 Class II Terminated There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
- 24 May 2018 Z-2150-2018 Class II Terminated There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
- 24 May 2018 Z-2151-2018 Class II Terminated There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
- 24 May 2018 Z-2152-2018 Class II Terminated There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
- 24 May 2018 Z-2153-2018 Class II Terminated There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
- 24 May 2018 Z-2154-2018 Class II Terminated There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
Show all 15 recalls
2018
- 24 May 2018 Z-2155-2018 Class II Terminated There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
- 24 May 2018 Z-2156-2018 Class II Terminated There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
- 24 May 2018 Z-2157-2018 Class II Terminated There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
- 24 May 2018 Z-2158-2018 Class II Terminated There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
2007
- 27 Apr 2007 Z-0459-2009 Unclassified (pre-2012) Terminated A breakage problem of the acrylic bundles at both distal and proximal ends of the light tube for the MD Laryngoscope Blade GreenLine D Mac 3 has been detected. If breakage occurs during use, there is the potential for leaving approximately a one inch piece of acrylic tube in the patient's mouth.
From the company website
Anesthesia and respiratory care products. Humidity Delivered Just Right Explore DuoTherm® Humidification System for personalized, accurate patient care Learn MoreSeven Days, One Simplified SolutionExplore NEW BALLARD™ 7Day Closed Suction System Learn MoreNew Distribution Partnership Now partnering with Asker Healthcare to better serve customers in the UK, France, and GermanyReady for Any Intubation Extensive endotracheal tube portfolio \[…\]
Frequently asked questions
How many devices does SunMed have in the registry?
The registry currently lists 1279 devices for SunMed. Devices recorded under merged duplicate company entries are counted once.
Which registries list SunMed's devices?
Among its 50 most recently registered devices, SunMed has devices listed in EUDAMED (3 devices) and FDA GUDID (47 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do SunMed's devices fall under?
Among its 50 most recently registered devices, the classes recorded for SunMed's devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for SunMed?
FDA recall records list 15 recalls initiated by SunMed, the most recent initiated on 24 May 2018. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for SunMed?
EUDAMED lists 1 certificate for SunMed (quality management system) under MDR. The most recent was issued on 26 Aug 2026.
What are the newest devices from SunMed in the registry?
The most recently registered devices listed for SunMed include SuperNO2VA Nasal PAP Ventilation Device, Large, SuperNO2VA Et Mask, Adult Large, SuperNO2VA Et Mask, Adult Medium and INTUBATION KIT 1904A5.