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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

SCH-001 — Class I MDR by American Well…

MD Atlas
American Well Corporation Ireland Limited

EUDAMED last updated this device on Apr 6, 2026

SCH-001

539154385SCH001B2

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: American Well Corporation Ireland Limited
UDI-DI code: 05391543850005
Reference / catalog number: SCH-001

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Manufacturer information

Organization name: American Well Corporation Ireland Limited
SRN: IE-MF-000050436
Manufacturer status: Active

Market distribution

Primary placement in Ireland; available across 1 country total.

Country	On market since	Until
IrelandPrimary placement	Nov 28, 2012	Still on market

Device identification

Trade name: not provided
UDI-DI code: 05391543850005
Basic UDI-DI: 539154385SCH001B2
Reference / catalog number: SCH-001
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Web-based mental health/function therapeutic software, screen viewed.
Additional information URL: https://silvercloud.amwell.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

This device is not currently linked to any other device.

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.