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

ROTAX TRIAL FEMUR S1 R — Class IIa MDR by groupe lépine

MD Atlas
groupe lépine

EUDAMED last updated this device on Jul 5, 2024

ROTAX TRIAL FEMUR S1 R

++M483L091104F9

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: groupe lépine
UDI-DI code: +M483K1901100
Reference / catalog number: K190110

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: groupe lépine
SRN: FR-MF-000001182
Manufacturer status: Active

Related devices

1 TROCART PIN Ø2.5 L100++M483L0911YNOn the market 12/14 L TRIAL HEAD Ø32 -4++M483L091104F9On the market 12/14 L TRIAL HEAD Ø32 0++M483L091104F9On the market 130° TROCHANTERIC MARKER++M483L0909Z3On the market 133/253/H48 BOWL++M483L0999ZWOn 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: ROTAX TRIAL FEMUR S1 R
UDI-DI code: +M483K1901100
Basic UDI-DI: ++M483L091104F9
Reference / catalog number: K190110
Issuing entity: HIBCC

Classification

Risk category: Class IIa
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: S1

EMDN nomenclature code(s)

L091104ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE

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