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

11228 — Class I MDR by Calvo Izquierdo S.L.

MD Atlas
Calvo Izquierdo S.L.

EUDAMED last updated this device on Dec 26, 2025

11228

8430655112XXHE

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Calvo Izquierdo S.L.
UDI-DI code: 08430655112285
Reference / catalog number: 11228

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: Calvo Izquierdo S.L.
SRN: ES-MF-000001063
Manufacturer status: Active

Related devices

BANDE EXTENSIBLE 10cm x 4m84306551100XDFOn the market BANDE EXTENSIBLE 5cm x 4m84306551100XDFOn the market BANDE EXTENSIBLE 7cm x 4m84306551100XDFOn the market 12021-01 AZUL/BLUE8430655120XXHBOn the market 12021-02 ROSA/PINK8430655120XXHBOn the market

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW007
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: 08430655112285
Basic UDI-DI: 8430655112XXHE
Reference / catalog number: 11228
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M0303010201ELASTIC FIXING BANDAGES, SELF-ADHESIVE, EXTENSIBLE IN ONE DIRECTION

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

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.