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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

IscAlert Introducer — Class IIa MDR by SENSOCURE AS

MD Atlas
SENSOCURE AS

EUDAMED last updated this device on Jun 3, 2025

IscAlert Introducer

709006232ISCALERTINTROVR

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SENSOCURE AS
UDI-DI code: 07090062320034
Reference / catalog number: 80007

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View device family (Basic UDI)

Manufacturer information

Organization name: SENSOCURE AS
SRN: NO-MF-000031688
Manufacturer status: Active

Critical warnings

4 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.
CW007
EUDAMED did not publish a description for this code.
CW011
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Norway; available across 1 country total.

Country	On market since	Until
NorwayPrimary placement		Still on market

Device identification

Trade name: IscAlert Introducer
UDI-DI code: 07090062320034
Basic UDI-DI: 709006232ISCALERTINTROVR
Reference / catalog number: 80007
Issuing entity: GS1

Classification

Risk category: Class IIa
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: 1.511 MU50
1.905 MU50
31.75 MU50

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)07090062320034

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

C0503CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY

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

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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.