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IH CCM Casting Abutment

EUDAMED

Class IIb (EU MDR)

Ref AIHCCARH4530Model IH IMPLANT SYSTEM Ref AIHCCAMH4030Ref AIHCCARN4530Ref AIHCCAMN4030Ref AIHCCARH4510D

by SEWONMEDIX Inc.

Identity

Trade Name
IH CCM Casting Abutment EUDAMED
Device Name
IH CCM Casting Abutment EUDAMED
Model / Reference
IH IMPLANT SYSTEM EUDAMED
AIHCCARH4530 EUDAMED
AIHCCAMH4030 EUDAMED
AIHCCARN4530 EUDAMED
AIHCCAMN4030 EUDAMED
AIHCCARH4510D EUDAMED

Identifiers

Primary DI / UDI-DI
08800041358496 EUDAMED
08800041358458 EUDAMED
08800041358519 EUDAMED
08800041358472 EUDAMED
08800041358526 EUDAMED
Basic UDI-DI
B-08800041358496 EUDAMED
B-08800041358458 EUDAMED
B-08800041358519 EUDAMED
B-08800041358472 EUDAMED
B-08800041358526 EUDAMED
EMDN Code
P01020101 DENTAL IMPLANTS EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Poland EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

Yes

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

IH CCM Casting Abutment by SEWONMEDIX Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

Manufacturer
SEWONMEDIX Inc.
EUDAMED SRN
KR-MF-000016194
Authorised Representative
Advena Limited MT-AR-000000234

Sources (5)

  • EUDAMED ca4a1956-0fba-4823-8f89-853bcb89d5bc 61 fields · synced Jul 24, 2026
  • EUDAMED 660c8f13-ddcf-4074-b012-d8f8735243b7 61 fields · synced May 17, 2026
  • EUDAMED 731de40b-4fa5-4ca3-8831-1af46e2ab0c0 61 fields · synced May 17, 2026
  • EUDAMED e0a26972-5aca-45b3-addc-0701ff75b351 61 fields · synced May 18, 2026
  • EUDAMED 7ef189a2-b935-43ed-8cb3-e92668dc2f6e 61 fields · synced May 18, 2026