EUDAMED last updated this device on Jun 8, 2026

Arrowpack ArroWrap SMS 55g

B-5386276ARROWRAPSMS55S7

On the marketClass I

Applicable legislation: —
Organization name: SAN.KO.M. d.o.o.
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 5386276ARROWRAPSMS55S7
Reference / catalog number: 735000000 - 735999999

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

Arrowpack ArroWrap SMS 55g is an EU-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by SAN.KO.M. d.o.o.. Placed on the EU market in Slovenia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: Arrowpack ArroWrap SMS 55g
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 5386276ARROWRAPSMS55S7
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: B-5386276ARROWRAPSMS55S7
Reference / catalog number: 735000000 - 735999999
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: HIBCC

Classification

Risk category: Class I
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: Arrowpack ArroWrap SMS 55g sterilization wraps for use with the following sterilization procedures: Steam Ethylene-Oxide Formaldehyde Plasma
Additional information URL: https://sankom.si/
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

5386276ARROWRAPSMS55S7

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

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EMDN nomenclature code(s)

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

S010399MATERIALS FOR PACKAGING PACKS TO BE STERILIZED - OTHER

Critical warnings

No critical warnings reported for this device.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Slovenia; available across 1 country total.

Country	On market since	Until
SloveniaPrimary placement	Nov 6, 2023	Still on market

Arrowpack ArroWrap SMS 55g

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Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

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Safety

Regulatory

Lifecycle

Market distribution

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Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

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Certificates

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