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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

0037504 — Class I MDR by Iberhospitex, S.A.

MD Atlas
Iberhospitex, S.A.

EUDAMED last updated this device on May 6, 2026

0037504

8428097OFPIV73

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Iberhospitex, S.A.
UDI-DI code: 08428097944007
Reference / catalog number: 0037504

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Manufacturer information

Organization name: Iberhospitex, S.A.
SRN: ES-MF-000000160
Manufacturer status: Active

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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.

Critical warnings

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

CW009
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Jul 11, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08428097944007
Basic UDI-DI: 8428097OFPIV73
Reference / catalog number: 0037504
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: IV Transparent dressing reinforced 11 X 14 CM
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 14 MU10
11 MU10

EMDN nomenclature code(s)

M04010202POLYURETHANE FIXING DRESSINGS

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