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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

CCZ1205048204 — Class I MDR by CARDIO CALM S.R.L.

MD Atlas
CARDIO CALM S.R.L.

EUDAMED last updated this device on Aug 4, 2025

CCZ1205048204

++B972ABPMWEBCOR18B

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: CARDIO CALM S.R.L.
UDI-DI code: B972CCZ12050482040
Reference / catalog number: CCZ1205048204

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Manufacturer information

Organization name: CARDIO CALM S.R.L.
SRN: IT-MF-000017950
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Italy; available across 1 country total.

Placed on the market in Italy; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: B972CCZ12050482040
Basic UDI-DI: ++B972ABPMWEBCOR18B
Reference / catalog number: CCZ1205048204
Issuing entity: HIBCC

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: —
Additional information URL: https://www.cardiocalm.com/manuals/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

B972CCZ12050482040

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

EMDN nomenclature code(s)

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

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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

Certificate health across this manufacturer's portfolio.

ITH 1343804 1Supplemented
Quality management systemNotified body: 1936Expiry: Apr 21, 2027