BIGmack

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 10000041

by AbleNet Inc.

Identity

Trade Name: BIGmack EUDAMEDFDA UDI
Generic Name: Uncarboxylated matrix Gla protein (ucMGP) IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name: BIGmack EUDAMED
Start your communication journey with a BIGmack speech device. With a press of the large colored top, an individual can communicate a single message up to 2-minutes long. New messages are easily and quickly recorded to the BIGmack on the fly throughout the day to provide opportunities to communicate in almost any scenario. Includes ableCARE on-demand support Built ableSTRONG to endure drops and other environmental conditions Made from ableSAFE materials and tested by third-party safety labs Common Uses Request like "I want" or "I need help" Participate in an activity with "turn the page" or "It's your turn" Tell your classmates what you did over the weekend during a morning meeting Add communication to a switch controlled toy or applianceg Features Better than ever digital sound output suitable for almost any environment Includes red, yellow, green, and blue colored tops Clear snap cover to attach picture symbols and provide communication context to the user Soft-touch coating makes the device easier to hold Symbol Overlays Symbol overlays are not included with the BIGmack. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device. FDA UDI
Model / Reference: 10000041 EUDAMEDFDA UDI
Description: Start your communication journey with a BIGmack speech device. With a press of the large colored top, an individual can communicate a single message up to 2-minutes long. New messages are easily and quickly recorded to the BIGmack on the fly throughout the day to provide opportunities to communicate in almost any scenario. Includes ableCARE on-demand support Built ableSTRONG to endure drops and other environmental conditions Made from ableSAFE materials and tested by third-party safety labs Common Uses Request like "I want" or "I need help" Participate in an activity with "turn the page" or "It's your turn" Tell your classmates what you did over the weekend during a morning meeting Add communication to a switch controlled toy or applianceg Features Better than ever digital sound output suitable for almost any environment Includes red, yellow, green, and blue colored tops Clear snap cover to attach picture symbols and provide communication context to the user Soft-touch coating makes the device easier to hold Symbol Overlays Symbol overlays are not included with the BIGmack. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device. FDA UDI

Identifiers

Catalog Number: 10000041 FDA UDI
Primary DI / UDI-DI: 00850011150061 EUDAMEDFDA UDI
Basic UDI-DI: 085001115010000041E8 EUDAMED
Direct Marketing DI: 00850011150061 EUDAMED
FDA Product Code: ILQ FDA UDI
EMDN Code: Y214212 VOICE GENERATORS EUDAMED
GMDN Term: Uncarboxylated matrix Gla protein (ucMGP) IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class: Class I EUDAMED
Class II FDA UDI
Regulation Number: 890.3710 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

BIGmack by AbleNet Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	085001115010000041E8	Class I	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: AbleNet Inc.
EUDAMED SRN: US-MF-000008722
Authorised Representative: EUCEREP B.V. NL-AR-000001966

Sources (2)

EUDAMED 855edd1b-345c-4947-874a-d92e6d7d420a 61 fields · synced Oct 6, 2026
FDA UDI 6a6dad6e-4a02-4930-9a33-dbebb04d3311 34 fields · synced May 30, 2026