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Monobind, Inc.

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000021611 FEI 2020726

Monobind, Inc. is a medical device manufacturer based in the United States, with 467 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II and I; EU IVD General and Class C) as of 13 Nov 2026.

Devices
467
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 395
  • EUDAMED 370
  • FDA 510(k) 23

A device listed in two registries counts in both.

Device classes
  • FDA Class II 244
  • FDA Class I 122
  • EU IVD General 49
  • EU Class C 29
  • FDA Unclassified 12
  • EU Class A 8
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN US-MF-000021611
  • FDA FEI 2020726
  • DUNS 083155515

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI
Authorised rep.
AR Experts B.V.NL
Authorised rep.
CEpartner4UNL

What Monobind, Inc. makes

Monobind, Inc. manufactures in vitro diagnostic (IVD) kits for a range of hormone and protein assays, including enzyme immunoassays (EIA) and chemiluminescent immunoassays (CLIA) for analytes such as total and free triiodothyronine (TT3, FT3), total thyroxine (TT4), free thyroxine (Free T4), thyroid stimulating hormone (TSH), parathyroid hormone (PTH), 25‑hydroxy vitamin D, human chorionic gonadotropin beta‑core fragment, IgE, hGH, AFP, estradiol (E2), IL‑6, and cardiac troponin I, among others.

These IVD kits are classified as Class I, Class II, or Not Classified (N) and are listed in the FDA UDI registry. Monobind, Inc. is based in the United States.

AI-generated from registry data, 4 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue467

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Rows 1-50 of 467

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Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000021611
FDA FEI number
2020726
DUNS number
083155515
EUDAMED status
Active
EUDAMED registered name
Monobind Inc.
Registered address
100, North Pointe Drive, 92630, Lake Forest, United States
Phone
+1 949 951 2665
PRRC contact
Tony Shatola(public in EUDAMED)

Frequently asked questions

How many devices does MONOBIND, INC. have in the registry?

The registry currently lists 467 devices for MONOBIND, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list MONOBIND, INC.'s devices?

Among its 50 most recently registered devices, MONOBIND, INC. has devices listed in EUDAMED (49 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do MONOBIND, INC.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for MONOBIND, INC.'s devices are Class II and IVD general. Each device page shows its own class and authorisation.

What are the newest devices from MONOBIND, INC. in the registry?

The most recently registered devices listed for MONOBIND, INC. include Anti-CCP IgG AccuLite CLIA Kit - 192 wells, E1 AccuLite CLIA Kit - 192 wells, Anti-SARS-CoV-2 IgG AccuLite CLIA Kit - 96 wells and Leptin AccuLite CLIA Kit - 96 wells.

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