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Organization name
UDI-DI code
Reference / catalog number

CA012XL/2 — Class IIa MDR by Intersurgical SpA

MD Atlas
Intersurgical SpA

EUDAMED last updated this device on May 26, 2026

CA012XL/2

80583230DCCASCHIKD

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Intersurgical SpA
UDI-DI code: 08058323000438
Reference / catalog number: CA012XL/2

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View device family (Basic UDI)

Manufacturer information

Organization name: Intersurgical SpA
SRN: IT-MF-000010729
Manufacturer status: Active

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Certificates

Certificate health across this manufacturer's portfolio.

ITH 1344699 1Supplemented
Quality management systemNotified body: 1936Expiry: Jan 24, 2028

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
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: 08058323000438
Basic UDI-DI: 80583230DCCASCHIKD
Reference / catalog number: CA012XL/2
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: XL

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.

R0301010401CPAP HELMETS AND KITS

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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