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

2242016 — Class I MDR by Fleming Comercial, S.A.

MD Atlas
Fleming Comercial, S.A.

EUDAMED last updated this device on Oct 13, 2022

2242016

8426828fajasacrolumbarKA

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fleming Comercial, S.A.
UDI-DI code: 08470003801546
Reference / catalog number: 2242016

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: Fleming Comercial, S.A.
SRN: ES-MF-000004259
Manufacturer status: Active

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 Spain; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08470003801546
Basic UDI-DI: 8426828fajasacrolumbarKA
Reference / catalog number: 2242016
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: Talla M / C.N. 380154.6 / Transpirable
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 80–100 MU10

EMDN nomenclature code(s)

Y060308LUMBOSACRAL SPINE ORTHOSES

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

Related devices

31050108426828bragacerradaLCOn the market 31050128426828bragacerradaLCOn the market 31050048426828bragacerradaLCOn the market 31050068426828bragacerradaLCOn the market 31050088426828bragacerradaLCOn 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.