BIG Step-by-Step

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 10000043

by AbleNet Inc.

Identity

Trade Name: BIG Step-by-Step EUDAMEDFDA UDI
Generic Name: Assistive speech generator FDA UDI
Device Name: BIG Step-by-Step EUDAMED
Move into multi-message communication with the BIG Step-by-Step speech device. Activate the large colored top to play the first message. When done, activate the top again to play another message. New sequences of messages are easily and quickly recorded to the BIG Step-by-Step on the fly, or use the levels pre-record up to three sets of messages ahead of time. 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 Record pages of a book to tell a story Count from 1 to 10 Ask a series of questions Add communication to a switch controlled toy or appliance 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 BIG Step-by-Step. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device. FDA UDI
Model / Reference: 10000043 EUDAMEDFDA UDI
Description: Move into multi-message communication with the BIG Step-by-Step speech device. Activate the large colored top to play the first message. When done, activate the top again to play another message. New sequences of messages are easily and quickly recorded to the BIG Step-by-Step on the fly, or use the levels pre-record up to three sets of messages ahead of time. 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 Record pages of a book to tell a story Count from 1 to 10 Ask a series of questions Add communication to a switch controlled toy or appliance 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 BIG Step-by-Step. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device. FDA UDI

Identifiers

Catalog Number: 10000043 FDA UDI
Primary DI / UDI-DI: 00850011150085 EUDAMEDFDA UDI
Basic UDI-DI: 085001115010000043EC EUDAMED
Direct Marketing DI: 00850011150085 EUDAMED
FDA Product Code: ILQ FDA UDI
EMDN Code: Y214212 VOICE GENERATORS EUDAMED
GMDN Term: Assistive speech generator 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

BIG Step-by-Step 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	085001115010000043EC	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 d055cbff-1670-455b-b71b-673e34de689d 61 fields · synced Oct 6, 2026
FDA UDI 803b6a92-9d4e-4e34-95de-6dc63661b097 34 fields · synced May 30, 2026