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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

CO0305 — Class I MDR by SC SPD STAR SRL

MD Atlas
SC SPD STAR SRL

EUDAMED last updated this device on May 8, 2026

CO0305

5944751COMPRESESWN

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SC SPD STAR SRL
UDI-DI code: 05944751001556
Reference / catalog number: CO0305

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View device family (Basic UDI)

Manufacturer information

Organization name: SC SPD STAR SRL
SRN: RO-MF-000004404
Manufacturer status: Active

Related devices

CC02B-05944751000689On the market CO03105944751COMPRESESWNOn the market CO03205944751COMPRESESWNOn the market CO03405944751COMPRESESWNOn the market CL07305944751IVDRC67On the market

Certificates

Certificate health across this manufacturer's portfolio.

MDR.2292-2025/0006Issued
Quality assuranceNotified body: 2292Expiry: Apr 14, 2030

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Romania; available across 1 country total.

Country	On market since	Until
RomaniaPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 05944751001556
Basic UDI-DI: 5944751COMPRESESWN
Reference / catalog number: CO0305
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: 5
Additional product description: Metoda de sterilizare: Oxid de Etilenă. Termen de valabilitate: 5 ani Conținut steril în condițiile păstrării intacte a ambalajului. A se utiliza exclusiv pentru uz extern ca barieră mecanică.sau absorbție a exudatelor. Înainte de utilizare, veriﬁcați integritatea plicului, precum și data limită de utilizare a produsului A nu se lăsa la îndemâna copiilor. Dispozitiv Medical
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.

M0201020101COTTON GAUZES, FOLDED, WITHOUT X-RAY DETECTABLE THREAD, STERILE

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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