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Organization name
UDI-DI code
Reference / catalog number

2G004512 — Class IIb MDD by NEURO FRANCE Implants

MD Atlas
NEURO FRANCE Implants

EUDAMED last updated this device on Jun 14, 2022

2G004512

B-03700527121635

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: NEURO FRANCE Implants
UDI-DI code: 03700527121635
Reference / catalog number: 2G004512

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Manufacturer information

Organization name: NEURO FRANCE Implants
SRN: FR-MF-000002210
Manufacturer status: Active

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246535B-03700527124025On the market 255040B-03700527119502On the market 245530B-03700527122458On the market 255030B-03700527119427On the market 240041B-03700527105994On 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.

Critical warnings

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

CW009
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW011
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	Oct 10, 2014	Still on market

Device identification

Trade name: not provided
UDI-DI code: 03700527121635
Basic UDI-DI: B-03700527121635
Reference / catalog number: 2G004512
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

P09070399IMPLANTABLE SPINAL STABILISATION OR FIXATION SYSTEMS - 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
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Software identification