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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

FF1001 — Class IIa MDD by FIM Médical

MD Atlas
FIM Médical

EUDAMED last updated this device on Jul 26, 2022

FF1001

B-03760253450034

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: FIM Médical
UDI-DI code: 03760253450034
Reference / catalog number: FF1001

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Manufacturer information

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

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW015
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Jan 1, 2010	Still on market

Device identification

Trade name: not provided
UDI-DI code: 03760253450034
Basic UDI-DI: B-03760253450034
Reference / catalog number: FF1001
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://www.fim-medical.com/audiolyser-adl20/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - 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

Related devices

FF1001376025345FF1001SXOn the market SS1101B-03760253450324On the market SP1MB-03760253450386On the market SP1B-03760253450379On the market Pince NezB-03760253450201On the market

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.