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Organization name
UDI-DI code
Reference / catalog number

38 33 11 — Class I MDR by SACIMEX

MD Atlas
SACIMEX

Manufacturer information

Organization name: SACIMEX
SRN: FR-MF-000011190
Manufacturer status: Active

Certificates

Certificate health across this manufacturer's portfolio.

2026 PR 0068Issued
Quality assuranceNotified body: 0318Expiry: Jan 13, 2031

EUDAMED last updated this device on Apr 24, 2026

38 33 11

3665946INS002XJ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SACIMEX
UDI-DI code: 03665946000346
Reference / catalog number: 38 33 11

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Manufacturer information

Organization name: SACIMEX
SRN: FR-MF-000011190
Manufacturer status: Active

Critical warnings

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

CW010
These devices may only be used in public or private hospitals in orthopaedic surgery and exclusively by surgeons with sufficient training and experience in the field of ligament reconstruction surgery, and having read this leaflet.

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: 03665946000346
Basic UDI-DI: 3665946INS002XJ
Reference / catalog number: 38 33 11
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: No clinical sizes registered for this device.

EMDN nomenclature code(s)

L0999ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY 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.

2026 PR 0068Issued
Quality assuranceNotified body: 0318Expiry: Jan 13, 2031

Manufacturer information

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38 33 11

Manufacturer information

Critical warnings

Market distribution

Device identification

Classification

Device details

EMDN nomenclature code(s)

Compliance flags

Safety

Substances

Regulatory

Lifecycle

UDI-PI traceability

Related devices

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