Acon Laboratories, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000023913 FEI 3003516723
Acon Laboratories, Inc. is a medical device manufacturer based in the United States, with 275 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class II, Class I and N; EU Class C) and 1 FDA recall as of 12 Nov 2026.
- Devices
- 275
- Registrations
- EUDAMEDFDA
- FDA recalls
- 1
Registry facts
- Registries
- FDA GUDID 176
- FDA 510(k) 91
- EUDAMED 8
- Device classes
- FDA Class II 156
- FDA Class I 104
- EU Class C 8
- FDA N 5
- FDA Unclassified 2
- Top EMDN categories
- FDA recalls
- Identifiers
- EUDAMED SRN US-MF-000023913
- FDA FEI 3003516723
- DUNS 781100966
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
- United States
- FDA FEI, FDA recalls
Catalogue
Search and filter all 275 devicesShowing 1-50 of 275
Company details
- EUDAMED SRN
- US-MF-000023913
- FDA FEI number
- 3003516723
- DUNS number
- 781100966
- EUDAMED status
- Active
- EUDAMED registered name
- ACON Laboratories, Inc.
- Registered address
- 5850 Oberlin Drive, #340, 92121, San Diego, United States
- Website
- aconlabs.com
- info@aconlabs.com
- Phone
- 858-875-8000
- PRRC contact
- Javorka Gunic
EUDAMED certificates
2 certificates2 valid, 0 expiredIVDR 2next expiry 4 Aug 2031
TÜV SÜD Product Service GmbH 0123 2 certificates
- V13 104507 0012 Active
Quality management system EU IVDR
- Issued
- 12 Oct 2026
- Expires
- 11 Oct 2031
- V76 104507 0014 Active
Technical documentation EU IVDR
- Issued
- 5 Aug 2026
- Expires
- 4 Aug 2031
FDA recalls
2015
- 17 Jun 2015 Z-2322-2015 Class III Terminated Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment.
Frequently asked questions
How many devices does Acon Laboratories, Inc. have in the registry?
The registry currently lists 275 devices for Acon Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Acon Laboratories, Inc.'s devices?
Among its 50 most recently registered devices, Acon Laboratories, Inc. has devices listed in EUDAMED (8 devices), FDA 510(k) (2 devices) and FDA GUDID (40 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Acon Laboratories, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Acon Laboratories, Inc.'s devices are Class I, Class II and IVDR Class C. Each device page shows its own class and authorisation.
Are there FDA recall records for Acon Laboratories, Inc.?
FDA recall records list 1 recall initiated by Acon Laboratories, Inc., the most recent initiated on 17 Jun 2015. 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 Acon Laboratories, Inc.?
EUDAMED lists 2 certificates for Acon Laboratories, Inc. (quality management system; technical documentation) under IVDR. 2 are recorded with the status issued. The most recent was issued on 12 Oct 2026.
What are the newest devices from Acon Laboratories, Inc. in the registry?
The most recently registered devices listed for Acon Laboratories, Inc. include Mission® Cholesterol Test Device 3-in-1 Lipid Panel, Mission® Cholesterol Meter, Mission® Cholesterol Optical Check Device and Mission® Cholesterol Monitoring System.