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

510002771 — Class I MDR by Orkla Cederroth, SAU

MD Atlas
Orkla Cederroth, SAU

EUDAMED last updated this device on Nov 27, 2023

510002771

8414797TF23HIDROBB

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Orkla Cederroth, SAU
UDI-DI code: 08402001009747
Reference / catalog number: 510002771

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: Orkla Cederroth, SAU
SRN: ES-MF-000003606
Manufacturer status: Active

Critical warnings

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

CW011
No utilizar en ampollas con sangre o que estén infactadas.
CW030
Los diabéticos deben consultar al médico antes de su utilización.
CW009
Su reutilización aumenta el riesgo de infección.

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: 08402001009747
Basic UDI-DI: 8414797TF23HIDROBB
Reference / catalog number: 510002771
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: Apósitos hidrocoloides surtidos indicado para ampollas, rozaduras y pequeñas heridas. Amortiguan la presión y la fricción en el área.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 6 unidades en total. Surtido de 2 tamaños: 61x35mm y 64x21mm.

EMDN nomenclature code(s)

M04040301HYDROCOLLOID DRESSINGS, NON-COMBINED

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

510302178414797TF07TEELBDWOn the market 3106858414797TF02PE00S5WOn the market 3106878414797TF02PE00S5WOn the market 3106868414797TF01PE00S5HOn the market 510300298414797TF02PE00S5WOn 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.