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iSy® Titanium base CAD/CAM free

EUDAMED

Class IIb (EU MDR)

Ref P2247.5210Ref P2265.4510Ref P2247.4510Ref P2247.4520

by ALTATEC GmbH

Identity

Trade Name
iSy® Titanium base CAD/CAM free EUDAMED
Device Name
iSy® Abutments EUDAMED
Model / Reference
P2247.5210 EUDAMED
P2265.4510 EUDAMED
P2247.4510 EUDAMED
P2247.4520 EUDAMED

Identifiers

Primary DI / UDI-DI
04099797020946 EUDAMED
04099797020991 EUDAMED
04099797020922 EUDAMED
04099797020939 EUDAMED
Basic UDI-DI
40997970001901000000000JL EUDAMED
Secondary DI
E219P224752101 EUDAMED
E219P226545101 EUDAMED
E219P224745101 EUDAMED
E219P224745201 EUDAMED
EMDN Code
P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

Yes

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Sutures

Yes

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

iSy® Titanium base CAD/CAM free by ALTATEC GmbH — Class IIb — 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
ALTATEC GmbH
EUDAMED SRN
DE-MF-000006230

Sources (4)

  • EUDAMED c7c34494-38c2-4e27-bffd-fad30bb43886 61 fields · synced Aug 4, 2026
  • EUDAMED e60e0b2a-b854-46c8-b661-ca10fa163958 61 fields · synced May 17, 2026
  • EUDAMED cf4f9e24-1dd5-4faa-99be-8d6135e018bb 61 fields · synced May 18, 2026
  • EUDAMED a4f8c40d-701a-425c-b08d-61a2e84b97d9 61 fields · synced May 19, 2026