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Organization name
UDI-DI code
Reference / catalog number

FORA IR20b — Class IIa MDD by ForaCare Suisse AG

MD Atlas
ForaCare Suisse AG

EUDAMED last updated this device on Aug 20, 2024

FORA IR20b

B-07640143657728

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: ForaCare Suisse AG
UDI-DI code: 07640143657728
Reference / catalog number: FORA IR20b

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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
See IFU

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: FORA IR20b
UDI-DI code: 07640143657728
Basic UDI-DI: B-07640143657728
Reference / catalog number: FORA IR20b
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: AAA Battery*2, Manual*1 warranty*1, probe cover*16
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V0301010201CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES)

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

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.