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

FB8C8X — Class IIa MDD by EUROSPINE SARL

MD Atlas
EUROSPINE SARL

EUDAMED last updated this device on Feb 16, 2023

FB8C8X

B-M614FB8C8X1

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: EUROSPINE SARL
UDI-DI code: M614FB8C8X1
Reference / catalog number: FB8C8X

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: EUROSPINE SARL
SRN: FR-MF-000001820
Manufacturer status: Active

Related devices

AIFL13-4B-M614AIFL1341On the market A2L13-9B-M614A2L1391On the market A2LL10-4SB-M614A2LL104S1On the market A2LL10-9SB-M614A2LL109S1On the market A2L11-9SB-M614A2L119S1On the market

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 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: M614FB8C8X1
Basic UDI-DI: B-M614FB8C8X1
Reference / catalog number: FB8C8X
Issuing entity: HIBCC

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://eurospine.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

L1199NEUROSURGERY 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.

FR25/00000203Issued
Quality management systemNotified body: 1639Expiry: Nov 4, 2030