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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

GLE9000426 — Class I MDR by S.B.M. SAS

MD Atlas
S.B.M. SAS

EUDAMED last updated this device on Mar 25, 2025

GLE9000426

376015400DT2021012TV

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: S.B.M. SAS
UDI-DI code: 03760304681059
Reference / catalog number: GLE9000426

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Manufacturer information

Organization name: S.B.M. SAS
SRN: FR-MF-000000214
Manufacturer status: Active

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PUL9000303376015400DT2019024VHOn the market 110026104376015400DT2019046VTOn the market 256412376015400DT2019046VTOn the market EPA9000303376015400DT2019024VHOn the market GLE9000409376015400DT2021011TTOn the market

Market distribution

Primary placement in France; available across 1 country total.

Placed on the market in France; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 03760304681059
Basic UDI-DI: 376015400DT2021012TV
Reference / catalog number: GLE9000426
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: Cannulated drill bit diameter 5 mm
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

L090999ORTHOPAEDIC SURGERY CUTTING 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

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.