Advanced Instruments, LLC
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000027205 FEI 1217058
Advanced Instruments, LLC is a medical device manufacturer based in the United States, with 107 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class I and II; EU Class A) and 3 FDA recalls as of 14 Nov 2026.
- Devices
- 107
- Registrations
- EUDAMEDFDA
- FDA recalls
- 31 ongoing
Registry facts
- Registries
- FDA GUDID 91
- FDA 510(k) 16
- EUDAMED 9
- Device classes
- FDA Class I 64
- FDA Class II 33
- EU Class A 9
- Top EMDN categories
- FDA recalls
- Sites and related companies
- Wmde B.V. authorised representative
- Identifiers
- EUDAMED SRN US-MF-000027205
- FDA FEI 1217058
- DUNS 125006353
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
- Authorised rep.
- Wmde B.V.NL
What Advanced Instruments, LLC makes
Advanced Instruments, LLC manufactures in-vitro diagnostics (IVDs) for osmolality measurement, including calibrators, controls, and semi-automated osmometric analysers like the Model 3250 and Osmo1® micro-osmometer. The company also produces haematological IVDs such as automated cell counters (e.g., GloCyte® systems) and full blood count controls, alongside conjugated bilirubin test kits for spectrophotometry. Single-use absorbent swabs and anaerobic atmospheric generation devices are part of its portfolio, along with vacuum preparation stations and related accessories.
The company’s devices are classified under EU Class A, Class I, and Class II categories, with listings in the EUDAMED registry and the FDA’s Unique Device Identifier (UDI) database. Advanced Instruments, LLC is based in the United States.
Catalogue
Search and filter all 107 devicesShowing 1-50 of 107
Company details
- EUDAMED SRN
- US-MF-000027205
- FDA FEI number
- 1217058
- DUNS number
- 125006353
- EUDAMED status
- Active
- EUDAMED registered name
- Advanced Instruments, LLC
- Registered address
- 2, Technology Way, 02062, Norwood, United States
- Website
- www.novabiomedical.com
- Phone
- +1 781-320-9000
- PRRC contact
- Autumn Collasius
FDA recalls
FDA recall records list 3 recalls initiated by Advanced Instruments, LLC, the earliest on 2011-01-19 and the most recent on 2024-03-11. By recorded status: 1 ongoing and 2 terminated. The reasons filed fall into these groups: electrical or power and performance or accuracy. 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 1
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 1
- 2025 0
- 2026 0
2024
- 11 Mar 2024 Z-1696-2024 Class II Ongoing System error messages may delay the ability to test patient samples and the need for frequent calibration due to results outside the expected range when testing controls.
Full distribution text
- 11 Mar 2024 Z-1696-2024 Class II Ongoing System error messages may delay the ability to test patient samples and the need for frequent calibration due to results outside the expected range when testing controls.
2018
- 7 Feb 2018 Z-0640-2019 Class II Terminated RBC Reagent failure. High fluorescent counts during RBC Reagent + Diluent QC check that will result in failed QC check, preventing user from testing patient samples for RBC.
2011
- 19 Jan 2011 Z-2068-2011 Unclassified (pre-2012) Terminated A poorly soldered power cord may pose a potential electrical shock hazard.
From the company website
Nova Biomedical provides innovative, high-quality analytical instruments and services for bioprocessing, clinical and veterinary industries.
Frequently asked questions
How many devices does Advanced Instruments, LLC have in the registry?
The registry currently lists 107 devices for Advanced Instruments, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Advanced Instruments, LLC's devices?
Among its 50 most recently registered devices, Advanced Instruments, LLC has devices listed in FDA GUDID (50 devices).
What risk classes do Advanced Instruments, LLC's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Advanced Instruments, LLC's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Advanced Instruments, LLC?
FDA recall records list 3 recalls initiated by Advanced Instruments, LLC, the most recent initiated on 11 Mar 2024. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Advanced Instruments, LLC in the registry?
The most recently registered devices listed for Advanced Instruments, LLC include Advanced Instruments RBC Reagent Filtration Kit 111014, Advanced Instruments Osmolality Linearity Set, 2mL 3MA002, Advanced Instruments OsmoPRO MAX Calibration Set 3MA552 and Advanced Instruments Protinol 3 Level Control - 3mL Vial - Pkg 9 3MA028.