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Organization name
UDI-DI code
Reference / catalog number

AS 6612 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 6612 WA

B-05907694954204

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: SMS Sp. z o.o.
UDI-DI code: 05907694954204
Reference / catalog number: 0973-211-008

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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 WAB-05907694954167On the market AS 446 WPAB-05907694954082On 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 13, 1989	Still on market

Device identification

Trade name: AS 6612 WA
UDI-DI code: 05907694954204
Basic UDI-DI: B-05907694954204
Reference / catalog number: 0973-211-008
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 66 sterilizers are intended for steam sterilization of surgical instruments, operation linen, dressing materials, rubber products, metal and plastic dishes and glass. The sterilizers are used in hospitals (CSSD, operating suites, kitchens, laundries). The AS 66 sterilizers, as they allow additional programs for sterilizing infusion liquids and microbiological cultures and nutrients to be set up, can be used in laboratories, as well as in pharmaceutical, food and cosmetics industries. Special sterilizers, equipped with quick cool-down system are also available.
Additional information URL: https://sms.com.pl/en/steam-sterilizers/as-66/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
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Software identification

UDI-DI DataMatrix

Encoded

(01)05907694954204

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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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