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Organization name
UDI-DI code
Reference / catalog number

Presse horizontale à charge… — Class I MDR by ML FUSION

MD Atlas
ML FUSION

EUDAMED last updated this device on Mar 10, 2022

Presse horizontale à charge frontale dossier réglable 200 kg

376036318machineXL

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ML FUSION
UDI-DI code: 03760363180005
Reference / catalog number: PRE852

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Manufacturer information

Organization name: ML FUSION
SRN: FR-MF-000020822
Manufacturer status: Active

Critical warnings

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

CW010
consulter le livret d'instructions et d'utilisation

Market distribution

Primary placement in France; available across 3 countries total.

Country	On market since	Until
FrancePrimary placement		Still on market
Belgium		Still on market
Luxembourg		Still on market

Device identification

Trade name: Presse horizontale à charge frontale dossier réglable 200 kg
UDI-DI code: 03760363180005
Basic UDI-DI: 376036318machineXL
Reference / catalog number: PRE852
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: Matériel de remise en forme adapté à la rééducation et destiné aux kinésithérapeutes et centres de rééducation.
Additional information URL: https://www.design-kinexo.fr/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z120616ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY

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.