Elitechgroup Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000006942
Elitechgroup Inc. is a medical device manufacturer based in the United States, with 217 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (EU Class A and IVD General; FDA Class I and II) and 5 FDA recalls as of 13 Nov 2026.
- Devices
- 217
- Registrations
- EUDAMED
- FDA recalls
- 5
Registry facts
- Registries
- FDA GUDID 126
- EUDAMED 102
- FDA 510(k) 17
- Device classes
- EU Class A 90
- FDA Class I 57
- FDA Class II 56
- EU IVD General 8
- EU Class I 2
- EU Class IIa 2
- Top EMDN categories
- FDA recalls
- Sites and related companies
- Medical Technology Promedt Consulting GmbH authorised representative
- Identifiers
- EUDAMED SRN US-MF-000006942
- DUNS 052423787
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA recalls
- Authorised rep.
- Medical Technology Promedt Consulting GmbHDE
What Elitechgroup Inc. makes
Elitechgroup Inc. manufactures sweat-induction iontophoresis systems and devices, including collection straps, electrode cable sets, and attachment strap retainers. They also produce cytological centrifuge funnels, microscope slide stainers, and dual sample chambers with Cytopads for laboratory use. Their portfolio includes evacuated and non-vacuum erythrocyte sedimentation rate (ESR) tubes, ESR analysers, and related control kits such as the Accu-Sed® Plus Norm & Abn ESR Control Kit. Additionally, they supply exogenous DNA/RNA internal control IVD kits, including the MGB Alert® BKV Probe Mix ASR, and freezing point osmometers like the FreezePoint® device.
The company's devices span multiple regulatory classes, including Class A, Class I, Class II, Class IIa, and IVD General. These products are listed in regulatory databases such as Eudamed and the FDA's UDI system. Elitechgroup Inc. is based in the United States.
Catalogue
Search and filter all 217 devicesShowing 1-50 of 217
Company details
- EUDAMED SRN
- US-MF-000006942
- DUNS number
- 052423787
- EU VAT number
- 870284733
- EUDAMED status
- Active
- EUDAMED registered name
- ELITechGroup Inc.
- EUDAMED abbreviated name
- EGI
- Registered address
- 370 West, 1700 South, 84321, Logan, United States
- Website
- www.elitechgroup.com
- Phone
- +1 435 752 4127
- PRRC contact
- Robert Ortiz
FDA recalls
2013
- 29 Aug 2013 Z-0732-2014 Class II Terminated High positive calcium bias on plasma sample versus results on serum
- 29 Aug 2013 Z-0733-2014 Class II Terminated High positive calcium bias on plasma sample versus results on serum
2010
- 12 Apr 2010 Z-1816-2010 Unclassified (pre-2012) Terminated The tube may fall out or separate from the Slider adapter
2009
- 4 Dec 2009 Z-1233-2010 Unclassified (pre-2012) Terminated Vital Diagnostics observed a bias in the Quality Control Consensus Program between published values for ALP on the ATAC 8000 and reported customer means. The ranges were adjusted to reflect the analyzer population.
- 4 Dec 2009 Z-1234-2010 Unclassified (pre-2012) Terminated Vital Diagnostics observed a bias in the Quality Control Consensus Program between published values for ALP on the ATAC 8000 and reported customer means. The ranges were adjusted to reflect the analyzer population.
Frequently asked questions
How many devices does ELITECHGROUP INC. have in the registry?
The registry currently lists 217 devices for ELITECHGROUP INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list ELITECHGROUP INC.'s devices?
Among its 50 most recently registered devices, ELITECHGROUP INC. has devices listed in FDA GUDID (50 devices).
What risk classes do ELITECHGROUP INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for ELITECHGROUP INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for ELITECHGROUP INC.?
FDA recall records list 5 recalls initiated by ELITECHGROUP INC., the most recent initiated on 29 Aug 2013. 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 ELITECHGROUP INC. in the registry?
The most recently registered devices listed for ELITECHGROUP INC. include Macroduct® Collection Strap Set, S, M, L, XL SS-259, Excyte Mini (9mm), Nanoduct® Electrode Cable Set Assembly RP-359 and Excyte® ESR Non-Vacuum Tubes EX-50100.