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

394N — Class IIa MDR by Ortopedia y Cirugía, S.L.

MD Atlas
Ortopedia y Cirugía, S.L.

EUDAMED last updated this device on Apr 29, 2026

394N

84350815CCEEN2

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Ortopedia y Cirugía, S.L.
UDI-DI code: 08435081503942
Reference / catalog number: 394N

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: Ortopedia y Cirugía, S.L.
SRN: ES-MF-000016977
Manufacturer status: Active

Related devices

4838428843508154838F3On the market 4838671843508154838F3On the market 4838596843508154838F3On the market 4515183843508159700F8On the market 4514926843508159700F8On the market

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW007
No utilizar si el envase individual está deteriorado
CW009
Producto de un solo uso

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Apr 28, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08435081503942
Basic UDI-DI: 84350815CCEEN2
Reference / catalog number: 394N
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 5
Additional product description: SOBRE 5 COMP. 45X45 17H 3T RX
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M0201030201LAPAROTOMY COTTON GAUZES, WITH X-RAY DETECTABLE THREAD, STERILE

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.

2024 PR 0016Issued
Quality assuranceNotified body: 0318Expiry: Feb 18, 2029