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

0067001 — Class III MDD by Iberhospitex, S.A.

MD Atlas
Iberhospitex, S.A.

EUDAMED last updated this device on Jun 27, 2022

0067001

B-08428097931106

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Iberhospitex, S.A.
UDI-DI code: 08428097931106
Reference / catalog number: 0067001

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

Related devices

0068001B-08428097953108On the market 0067002B-08428097931205On the market 0067003B-08428097931304On the market 0067102B-08428097931502On the market 0067103B-08428097931601On the market

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: 08428097931106
Basic UDI-DI: B-08428097931106
Reference / catalog number: 0067001
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: 6 MU50
1.25 MU50

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

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.