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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

Forma Health — Class I MDR by FORMA HEALTH…

MD Atlas
FORMA HEALTH TECHNOLOGIES S.L.

EUDAMED last updated this device on May 7, 2026

Forma Health

8437027694FormaSM

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: FORMA HEALTH TECHNOLOGIES S.L.
UDI-DI code: 08437027694004
Reference / catalog number: Forma Health

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Manufacturer information

Organization name: FORMA HEALTH TECHNOLOGIES S.L.
SRN: ES-MF-000042000
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW030
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement		Still on market

Device identification

Trade name: Forma Health
UDI-DI code: 08437027694004
Basic UDI-DI: 8437027694FormaSM
Reference / catalog number: Forma Health
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: —
Additional information URL: No additional information URL provided by the manufacturer.
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.