Skip to content

Cell Marque Corporation

Active in EUDAMED
Also registered as CELL MARQUE CORP.

United Statesfrom SRN EUDAMED FDA SRN US-MF-000028332 FEI 3017212430

Cell Marque Corporation is a medical device manufacturer based in the United States, with 2,367 devices listed in FDA GUDID and EUDAMED (FDA Class I; EU Class C, IVD General and Class A) and 18 FDA recalls as of 12 Nov 2026.

Devices
2,367
Registrations
EUDAMEDFDA
FDA recalls
181 ongoing

Registry facts

Counted by deviCERTS from registry records, 12 Nov 2026

Registries
  • FDA GUDID 2,181
  • EUDAMED 1,673

A device listed in two registries counts in both.

Device classes
  • FDA Class I 1,918
  • EU Class C 304
  • EU IVD General 107
  • EU Class A 31
  • EU Class B 7
Top EMDN categories
FDA recalls
Sites and related companies
Identifiers
  • EUDAMED SRN US-MF-000028332
  • FDA FEI 3017212430
  • DUNS 025048773

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI, FDA recalls
Authorised rep.
Emergo Europe B.V.NL

Catalogue2,367

Newest first, rows 1-50 of 2,367

Search and filter all 2,367 devices
Skip device list

Rows 1-50 of 2,367

Showing 1-50 of 2,367

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000028332
FDA FEI number
3017212430
DUNS number
025048773
EUDAMED status
Active
EUDAMED registered name
Cell Marque Corporation
EUDAMED abbreviated name
Cell Marque
Registered address
6600, Sierra College Blvd, 95677, Rocklin, United States
Phone
+1 916 746 8900
PRRC contact
Cheryl Prichard(public in EUDAMED)

FDA recalls18

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

  • 2017 12
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 3
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

3 initiated before 2017

Showing the 10 most recent of 18 recalls.

  • 2021

    • 15 Jul 2021 Z-2311-2021 Class III Ongoing Mouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec 2023. The correct expiry date is 31 Dec 2022. If used beyond expiry, the material performance is likely to decrease and may be observed as weak or no staining, and there is a potential risk that a false negative result could be recorded and may lead to delay of diagnosis due to retest. Distribution: Worldwide distribution - US Nationwide distribution in the states of OR, DC, NJ, CA and the countries of Canada, Mexico,…
      Full distribution text Worldwide distribution - US Nationwide distribution in the states of OR, DC, NJ, CA and the countries of Canada, Mexico, South Korea, Brazil, Thailand, Argentina.
    • 27 May 2021 Z-2105-2021 Class II Terminated Product distributed for use as an In-vitro Diagnostics without FDA clearance Distribution: US: AL, AR, AZ, CA, FL, HI, ID, IL, KY, MN, MT, NC, NH, NY, PA, SC, VA, WI OUS: N/A
    • 27 May 2021 Z-2106-2021 Class II Terminated Product distributed for use as an In-vitro Diagnostics without FDA clearance Distribution: US: AL, AR, AZ, CA, FL, HI, ID, IL, KY, MN, MT, NC, NH, NY, PA, SC, VA, WI OUS: N/A

  • 2017

    • 5 May 2017 Z-2199-2017 Class II Terminated Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act. Distribution: Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
    • 5 May 2017 Z-2200-2017 Class II Terminated Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act. Distribution: Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
    • 5 May 2017 Z-2201-2017 Class II Terminated Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act. Distribution: Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
    • 5 May 2017 Z-2202-2017 Class II Terminated Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act. Distribution: Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
    • 5 May 2017 Z-2203-2017 Class II Terminated Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act. Distribution: Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
    • 5 May 2017 Z-2204-2017 Class II Terminated Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act. Distribution: Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
    • 5 May 2017 Z-2205-2017 Class II Terminated Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act. Distribution: Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
Show all 18 recalls

  • 2017

    • 5 May 2017 Z-2206-2017 Class II Terminated Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act. Distribution: Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
    • 5 May 2017 Z-2207-2017 Class II Terminated Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act. Distribution: Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
    • 5 May 2017 Z-2208-2017 Class II Terminated Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act. Distribution: Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
    • 5 May 2017 Z-2209-2017 Class II Terminated Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act. Distribution: Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
    • 5 May 2017 Z-2210-2017 Class II Terminated Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act. Distribution: Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.

  • 2016

    • 10 May 2016 Z-2038-2016 Class II Terminated Cell Marque became aware of some lots of SIOOA I (EP I84) Rabbit Monoclonal Antibody, catalogue numbers 408R-14, 408R-15, and 408R-16, that exhibited an unacceptable IHC test result. Distribution: Distributed in the states of MA, CA, and WA and the countries of Australia, Denmark, Turkey, Germany, Russia, Slovenia,…
      Full distribution text Distributed in the states of MA, CA, and WA and the countries of Australia, Denmark, Turkey, Germany, Russia, Slovenia, Netherlands and Zambia.
      Submission number: K133845

  • 2012

    • 23 Jan 2012 Z-1176-2012 Not yet classified Terminated Letter received from supplier that material received in October 2009 was labeled as CD7, but was actually CD 2. Distribution: Worldwide Distribution - USA (nationwide) and the countries of Australia, Greece, Turkey, Italy, The Netherlands, Spain,…
      Full distribution text Worldwide Distribution - USA (nationwide) and the countries of Australia, Greece, Turkey, Italy, The Netherlands, Spain, Portugal, France, Israel, S. Korea, Pakistan, Morocco, Russia and Brazil.

  • 2011

    • 12 Jul 2011 Z-3110-2011 Unclassified (pre-2012) Terminated Incorrect label on product bottle, although labeling on outer box is correct. Distribution: Worldwide distribution: USA (nationwide) include state of : CA and country of: Great Britain.

Frequently asked questions

How many devices does CELL MARQUE CORPORATION have in the registry?

The registry currently lists 2367 devices for CELL MARQUE CORPORATION. Devices recorded under merged duplicate company entries are counted once.

Which registries list CELL MARQUE CORPORATION's devices?

Among its 50 most recently registered devices, CELL MARQUE CORPORATION has devices listed in EUDAMED (50 devices).

What risk classes do CELL MARQUE CORPORATION's devices fall under?

Among its 50 most recently registered devices, the classes recorded for CELL MARQUE CORPORATION's devices are IVDR Class C and IVD general. Each device page shows its own class and authorisation.

Are there FDA recall records for CELL MARQUE CORPORATION?

FDA recall records list 18 recalls initiated by CELL MARQUE CORPORATION, the most recent initiated on 15 Jul 2021. 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 CELL MARQUE CORPORATION in the registry?

The most recently registered devices listed for CELL MARQUE CORPORATION include ARID1A (EP303) Rabbit Monoclonal Primary Antibody, Herpes Simplex Virus II (3C5.2) Mouse Monoclonal Antibody, Herpes Simplex Virus I (10A3) Mouse Monoclonal Antibody and Her2/Neu (SP3) Rabbit Monoclonal Antibody.

Generated automatically from registry data and not verified by a human reviewer.