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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

58.FXX.XXL — Class I MDR by SC MEDICA

MD Atlas
SC MEDICA

EUDAMED last updated this device on Apr 23, 2026

58.FXX.XXL

377001950357001DE

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SC MEDICA
UDI-DI code: 03770019503324
Reference / catalog number: 58.FXX.XXL

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Manufacturer information

Organization name: SC MEDICA
SRN: FR-MF-000002722
Manufacturer status: Active

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57.005.11SB-03770019503096On the market 57.005.10SB-03770019503089On the market 57.005.13SB-03770019503102On the market 57.005.08SB-03770019503065On the market 57.005.09SB-03770019503072On 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.

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: 03770019503324
Basic UDI-DI: 377001950357001DE
Reference / catalog number: 58.FXX.XXL
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: Same as screw diameter
Same as screw length

EMDN nomenclature code(s)

Z12130503ORTHOPAEDIC SURGICAL DRILLS

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