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ASSOCIATES OF CAPE COD, INC.

US

Last updated September 17, 2026

Information

Country
US
Address
124 Bernard E. Saint Jean Drive, E Falmouth, MA, 02536
Website
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LinkedIn
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Facebook
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Email
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Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
1219145
DUNS Number
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Catalogue (4)

DeviceModel / ReferenceRegistriesClassStatus
Fungitell STAT 1
FDA UDI
N/AActive
BG Analytics Software 0
FDA UDI
Class IActive
Glucatell DEN040003
FDA 510(k)
Class IIActive
Fungitell STAT K191167
FDA 510(k)
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

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Authorities

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Aug 17, 2022Z-1774-2022—terminated

Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes