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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

CAP-SP1 — Class I MDR by SPECTRUM MEDICAL SRL

MD Atlas
SPECTRUM MEDICAL SRL

EUDAMED last updated this device on Jun 19, 2025

CAP-SP1

8051160300136RB

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SPECTRUM MEDICAL SRL
UDI-DI code: 18051160302137
Reference / catalog number: CAP-SP1

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Manufacturer information

Organization name: SPECTRUM MEDICAL SRL
SRN: IT-MF-000009234
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 18051160302137
Basic UDI-DI: 8051160300136RB
Reference / catalog number: CAP-SP1
Issuing entity: GS1

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: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

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

C030199EXTRACORPOREAL AND ASSISTED CIRCULATION DEVICES - OTHER

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.

ITD 1344656 1Amended
Quality assuranceNotified body: 1936Expiry: Apr 8, 2028