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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

SP1M — Class IIa MDD by FIM Médical

MD Atlas
FIM Médical

EUDAMED last updated this device on Jul 7, 2025

SP1M

B-03760253450386

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: FIM Médical
UDI-DI code: 03760253450386
Reference / catalog number: SP1M

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Manufacturer information

Organization name: FIM Médical
SRN: FR-MF-000017090
Manufacturer status: Active

Market distribution

Primary placement in France; available across 3 countries total.

Country	On market since	Until
FrancePrimary placement		Still on market
Germany		Still on market
Italy		Still on market

Device identification

Trade name: not provided
UDI-DI code: 03760253450386
Basic UDI-DI: B-03760253450386
Reference / catalog number: SP1M
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: —
Additional information URL: https://docs.fim-medical.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z1399NON-SPECIFIC CONSUMABLES FOR DIAGNOSTIC INSTRUMENTS - OTHER

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

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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.