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MONARCH LABS, LLC.

US

Last updated September 17, 2026

Information

Country
US
Address
17875 SKY PARK CIRCLE, SUITE K, IRVINE, CA, 92614
Website
—
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
3005735989
DUNS Number
—

Catalogue (27)

DeviceModel / ReferenceRegistriesClassStatus
LeFlap 66
FDA UDI
UActive
Creature Comforts 2424
FDA UDI
UActive
LeSoc 24x36
FDA UDI
UActive
LeFlap DuJour 88
FDA UDI
UActive
Creature Comforts KH
FDA UDI
UActive
Creature Comforts 88
FDA UDI
UActive
LeFlap DuJour 44
FDA UDI
UActive
Sheer Comfort KH
FDA UDI
UActive
LeFlap 33
FDA UDI
UActive
Medicinal Maggots 250
FDA UDI
UActive
Medical Maggots 250
FDA UDI
UActive
LeSoc 2X3
FDA UDI
UActive
LeSoc 4x6
FDA UDI
UActive
Creature Comforts 44
FDA UDI
UActive
Creature Comfort 1212
FDA UDI
UActive
Creature Comforts PH
FDA UDI
UActive
Sheer Comfort 44
FDA UDI
UActive
LeSoc 6x8
FDA UDI
UActive
LeSoc 18x24
FDA UDI
UActive
Sheer Comfort PH
FDA UDI
UActive
Sheer Comfort 1212
FDA UDI
UActive
LeSoc 8x12
FDA UDI
UActive
LeSoc 12x18
FDA UDI
UActive
Sheer Comfort 88
FDA UDI
UActive
Sheer Comfort 2424
FDA UDI
UActive
Medical Maggots, Lesoc K102827
FDA 510(k)
UActive
Medical Maggots, Creature Comforts K072438
FDA 510(k)
UActive

Related Companies

Authorised Representatives

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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
May 3, 2009Z-2207-2010—terminated

Monarch Labs initiated the field notification regarding their Medical Maggots from Batch MM090406 with the accessory LeFlap dressing due a customer complaint from a physician of a patient developing cellulitis after using maggots from the affected batch.