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Organization name
UDI-DI code
Reference / catalog number

FORA 6 𝝱-Ketone Test Strip — IVDD — Self-testing IVDD

MD Atlas
ForaCare Suisse AG

EUDAMED last updated this device on Oct 31, 2025

FORA 6 𝝱-Ketone Test Strip

B-07640143650118

On the marketIVDD — Self-testing

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: ForaCare Suisse AG
UDI-DI code: 07640143650118
Reference / catalog number: ACS053

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Manufacturer information

Organization name: ForaCare Suisse AG
SRN: CH-MF-000019906
Manufacturer status: Active

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Critical warnings

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

CW010
Consult instructions for use

Market distribution

Primary placement in Italy; available across 1 country total.

Placed on the market in Italy; per-country availability dates not published.

Device identification

Trade name: FORA 6 𝝱-Ketone Test Strip
UDI-DI code: 07640143650118
Basic UDI-DI: B-07640143650118
Reference / catalog number: ACS053
Issuing entity: GS1

Classification

Risk category: IVDD — Self-testing
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: 𝝱-Ketone Test Strip 25 pcs foil, Strip manual, Code card
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0101060110KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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.