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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

Supraflex Cruz — Class III MDD by Sahajanand Medical…

MD Atlas
Sahajanand Medical Technologies Ireland Limited

EUDAMED last updated this device on Sep 22, 2022

Supraflex Cruz

B-05397217004293

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Sahajanand Medical Technologies Ireland Limited
UDI-DI code: 05397217004293
Reference / catalog number: FGTZ300028IE

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Manufacturer information

Organization name: Sahajanand Medical Technologies Ireland Limited
SRN: IE-MF-000016121
Manufacturer status: Active

Related devices

Supraflex CruzB-05397217004309On the market Supraflex CruzB-05397217004323On the market Supraflex CruzB-05397217004248On the market Supraflex CruzB-05397217004132On the market Supraflex CruzB-05397217003913On the market

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

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

CW010
EUDAMED did not publish a description for this code.
CW264
EUDAMED did not publish a description for this code.
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.

Market distribution

Primary placement in Ireland; available across 1 country total.

Country	On market since	Until
IrelandPrimary placement		Still on market

Device identification

Trade name: Supraflex Cruz
UDI-DI code: 05397217004293
Basic UDI-DI: B-05397217004293
Reference / catalog number: FGTZ300028IE
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: Sirolimus Eluting Cobalt Chromium Coronary Stent System
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 28 MU50
3 MU50

EMDN nomenclature code(s)

P070402010301CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS

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