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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

U-010/1 — Class I MDD by EUROSPINE SARL

MD Atlas
EUROSPINE SARL

EUDAMED last updated this device on Feb 24, 2023

U-010/1

B-M614U01011

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: EUROSPINE SARL
UDI-DI code: M614U01011
Reference / catalog number: U-010/1

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Manufacturer information

Organization name: EUROSPINE SARL
SRN: FR-MF-000001820
Manufacturer status: Active

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Critical warnings

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

CW010
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		Still on market

Device identification

Trade name: not provided
UDI-DI code: M614U01011
Basic UDI-DI: B-M614U01011
Reference / catalog number: U-010/1
Issuing entity: HIBCC

Classification

Risk category: Class I
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)

L1199NEUROSURGERY INSTRUMENTS, REUSABLE- 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

Certificates

Certificate health across this manufacturer's portfolio.

FR25/00000203Issued
Quality management systemNotified body: 1639Expiry: Nov 4, 2030