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Organization name
UDI-DI code
Reference / catalog number

0037449 — Class I MDR by Iberhospitex, S.A.

MD Atlas
Iberhospitex, S.A.

EUDAMED last updated this device on May 6, 2026

0037449

8428097CATP6L

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Iberhospitex, S.A.
UDI-DI code: 08428097939300
Reference / catalog number: 0037449

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Manufacturer information

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

Critical warnings

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

CW009
EUDAMED did not publish a description for this code.
CW020
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: 08428097939300
Basic UDI-DI: 8428097CATP6L
Reference / catalog number: 0037449
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: Bolsa autoadhesiva para catéteres
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 5 MU10
16 MU10

EMDN nomenclature code(s)

M04010199ADHESIVE DRESSINGS, WITH ABSORBENT PAD - OTHER

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

0068001B-08428097953108On the market 0067002B-08428097931205On the market 0067003B-08428097931304On the market 0067001B-08428097931106On the market 0067102B-08428097931502On the market

Certificates

Certificate health across this manufacturer's portfolio.

2025 CR 0045Issued
Quality management systemNotified body: 0318Expiry: Jul 1, 2029
2024 PR 0030Issued
Quality assuranceNotified body: 0318Expiry: Jul 1, 2029
ES22/00000630Amended
Quality management systemNotified body: 1639Expiry: Oct 10, 2027