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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

0067353 — Class III MDD by Iberhospitex, S.A.

MD Atlas
Iberhospitex, S.A.

EUDAMED last updated this device on Jun 28, 2022

0067353

B-08428097930406

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Iberhospitex, S.A.
UDI-DI code: 08428097930406
Reference / catalog number: 0067353

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Manufacturer information

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

Critical warnings

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

CW011
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW020
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Spain; available across 2 countries total.

Country	On market since	Until
SpainPrimary placement	Jun 29, 2020	Still on market
Croatia	Sep 30, 2020	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08428097930406
Basic UDI-DI: B-08428097930406
Reference / catalog number: 0067353
Issuing entity: GS1

Classification

Risk category: Class III
Applicable legislation: MDD [Directive 93/42/EEC 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: 15 MU50
SC:3,50 / NC: 4,00 mm

EMDN nomenclature code(s)

C010401020101PTCA BALLOON DILATION CATHETERS

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