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Mouthpiece and Filter ABC

EUDAMED

Class IIa (EU MDR)

Ref 11-200-08-01Model Mouthpiece and Filter ABCRef 12-210Ref 11-200-08-10

by Aktina Medical Corp

Identity

Trade Name
Mouthpiece and Filter ABC EUDAMED
Device Name
ABC Mouthpiece and Filter Kit (20 per box) EUDAMED
Model / Reference
Mouthpiece and Filter ABC EUDAMED
11-200-08-01 EUDAMED
12-210 EUDAMED
11-200-08-10 EUDAMED

Identifiers

Primary DI / UDI-DI
+B3651120008011 EUDAMED
+B365122100 EUDAMED
+B3651120008102 EUDAMED
Basic UDI-DI
++B3651120008ABCVW EUDAMED
Direct Marketing DI
+B3651120008011 EUDAMED
+B365122100 EUDAMED
+B3651120008102 EUDAMED
EMDN Code
Z11010185 LINEAR ACCELERATORS - CONSUMABLES EUDAMED
Z11010199 LINEAR ACCELERATORS – OTHER EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Austria EUDAMED

Clinical & Handling

Sterile

No

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

Mouthpiece and Filter ABC by Aktina Medical Corp — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Manufacturer's product page: ABC Mouthpiece Filter Kit

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Aktina Medical Corp
EUDAMED SRN
US-MF-000005935
Authorised Representative
European Healthcare & Device Solutions Ltd. IE-AR-000003999

Sources (3)

  • EUDAMED 554f6036-40b1-441d-8c50-7bda4431759f 61 fields · synced Oct 5, 2026
  • EUDAMED 65162e3f-8cb0-4610-aa2f-4ad57cab1dde 61 fields · synced May 17, 2026
  • EUDAMED eca3c4b9-2582-4406-b337-c69a97e48c42 61 fields · synced May 17, 2026