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

16110000 — Class I MDR by CARDIVAIS S.A.

MD Atlas
CARDIVAIS S.A.

EUDAMED last updated this device on Jan 16, 2026

16110000

842965905809LJ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: CARDIVAIS S.A.
UDI-DI code: 08429659006003
Reference / catalog number: 16110000

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: CARDIVAIS S.A.
SRN: ES-MF-000017980
Manufacturer status: Active

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: 08429659006003
Basic UDI-DI: 842965905809LJ
Reference / catalog number: 16110000
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: Prevention of cross-infection in the operating room. Includes gauze dressings for use as a mechanical barrier, for compression, or for absorbing exudate, and examination gloves.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

T0203DRESSING AND ASSISTANCE KITS

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

12201501842965905804L8On the market 12002220842965905805LAOn the market 16130500842965905808LGOn the market 16100202842965905806LCOn the market 425001/01842965905796M2On the market

Certificates

Certificate health across this manufacturer's portfolio.

2025 PR 0047Issued
Quality assuranceNotified body: 0318Expiry: Apr 20, 2030
ES23/00000553Issued
Quality management systemNotified body: 1639Expiry: May 30, 2028