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Organization name
UDI-DI code
Reference / catalog number

AS 446 WA — Class IIb MDD by SMS Sp. z o.o.

MD Atlas
SMS Sp. z o.o.

EUDAMED last updated this device on May 19, 2023

AS 446 WA

B-05907694954167

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: SMS Sp. z o.o.
UDI-DI code: 05907694954167
Reference / catalog number: 0973-211-200

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View device family (Basic UDI)

Manufacturer information

Organization name: SMS Sp. z o.o.
SRN: PL-MF-000010604
Manufacturer status: Active

Related devices

AS 366 WPAB-05907694954150On the market 0973-211-205B-05907694954365On the market AS 446 PAB-05907694954389On the market AS 446 WPAB-05907694954082On the market 0973-213-172B-05907694954372On the market

Certificates

Certificate health across this manufacturer's portfolio.

1434-MDR-012/2024Issued
Quality management systemNotified body: 1434Expiry: Jan 29, 2030

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement	Mar 9, 1998	Still on market

Device identification

Trade name: AS 446 WA
UDI-DI code: 05907694954167
Basic UDI-DI: B-05907694954167
Reference / catalog number: 0973-211-200
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The AS 44 series sterilizers are intended for steam sterilization of surgical instruments, operation linen, dressing materials, rubber products, metal and plastic dishes, glass, infusion liquids, microbiological cultures and nutrients. The sterilizers are used in hospitals, clinics, outpatient clinics, pharmacies and laboratories etc.
Additional information URL: https://sms.com.pl/en/steam-sterilizers/as-44/
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.

Z12011304AUTOCLAVES WITH A CHAMBER LARGER THAN OR EQUAL TO 1 STANDARD STERILISATION UNIT

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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