Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

Hex Driver (5mm/8mm) — Class I MDR by OrthoXel DAC

MD Atlas
OrthoXel DAC

EUDAMED last updated this device on Feb 12, 2025

Hex Driver (5mm/8mm)

539152958285278

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: OrthoXel DAC
UDI-DI code: 05391529582852
Reference / catalog number: INS-1075

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: OrthoXel DAC
SRN: IE-MF-000000574
Manufacturer status: Active

Related devices

"Orange Ø4.9mm Twist Drill X Length 370mm (Use Ø6.0mm Locking Screw)"B-05391529582661On the market 3.5mm Hex Short Driver Shaft539152958517474On the market 3.5mm Hex Short Driver ShaftB-05391529585174On the market AO Mount Drill Extension (Length 136.5mm)B-05391529584207On the market Apex Femoral Nail GT Right Ø 11.0 x 380mmB-05391529587055On 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

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 Ireland; available across 1 country total.

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

Device identification

Trade name: Hex Driver (5mm/8mm)
UDI-DI code: 05391529582852
Basic UDI-DI: 539152958285278
Reference / catalog number: INS-1075
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