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

FLEXION HEMI SPACER H15 — Class I MDR by groupe lépine

MD Atlas
groupe lépine

EUDAMED last updated this device on Jul 11, 2024

FLEXION HEMI SPACER H15

++M483L0909Z3

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: groupe lépine
UDI-DI code: +M483GNABO0150
Reference / catalog number: GNA BO015

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.

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

Device identification

Trade name: FLEXION HEMI SPACER H15
UDI-DI code: +M483GNABO0150
Basic UDI-DI: ++M483L0909Z3
Reference / catalog number: GNA BO015
Issuing entity: HIBCC

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)

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