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5 X 450mm Probe for Elite Suction Irrigation Set

EUDAMED

Class IIa (EU MDR)

Ref SI0016Model ASI-A20000, ASI-A20010, ASI-A25000, ASI-A27000, ASI-A2700Z, ASI-B20000, ASI-B20030, ASI-C20060, ASI-C2006Z, ASI-0X50X0, ASI-0X70X0, ASI-0X90X0, ASI-1X00X0, ASI-1X50X0, ASI-1X70X0, ASI-2X10X0, ASI-2X50X0, ASI-3X00X0

by Advanced Medical Design Co., Ltd.

Identity

Trade Name
5 X 450mm Probe for Elite Suction Irrigation Set EUDAMED
Device Name
Suction Irrigation Set EUDAMED
Model / Reference
ASI-A20000, ASI-A20010, ASI-A25000, ASI-A27000, ASI-A2700Z, ASI-B20000, ASI-B20030, ASI-C20060, ASI-C2006Z, ASI-0X50X0, ASI-0X70X0, ASI-0X90X0, ASI-1X00X0, ASI-1X50X0, ASI-1X70X0, ASI-2X10X0, ASI-2X50X0, ASI-3X00X0 EUDAMED
SI0016 EUDAMED

Identifiers

Primary DI / UDI-DI
04711605993777 EUDAMED
Basic UDI-DI
471160599ASI016Q EUDAMED
EMDN Code
A03040299 IRRIGATION KITS, SINGLE-USE - OTHER EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Croatia EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

5 X 450mm Probe for Elite Suction Irrigation Set by Advanced Medical Design Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Advanced Medical Design Co., Ltd.
EUDAMED SRN
TW-MF-000019772
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (1)

  • EUDAMED 15f0629c-ed17-4674-ab89-9dd2b287ccb1 61 fields · synced Jun 19, 2026