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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

20 COMPARTMENT ADHESIVE GAUZE… — Class I MDR by Surgika srl

MD Atlas
Surgika srl

EUDAMED last updated this device on Apr 16, 2024

20 COMPARTMENT ADHESIVE GAUZE COUNTER POCKET CM.50X55 IN TRANSPARENT PE

805961777ALL009EA

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Surgika srl
UDI-DI code: 08059617778293
Reference / catalog number: S06ALL0309

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View device family (Basic UDI)

Manufacturer information

Organization name: Surgika srl
SRN: IT-MF-000024206
Manufacturer status: Active

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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

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

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.

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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: 20 COMPARTMENT ADHESIVE GAUZE COUNTER POCKET CM.50X55 IN TRANSPARENT PE
UDI-DI code: 08059617778293
Basic UDI-DI: 805961777ALL009EA
Reference / catalog number: S06ALL0309
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.

T030103ATRAUMATIC INSERTS FOR INSTRUMENTS

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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