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Paper Points

EUDAMED

Class IIa (EU MDR)

Ref PP02.000.040

by Sure Dent Corporation

Identity

Trade Name
Paper Points EUDAMED
Device Name
Sterile Absorbent Paper Points EUDAMED
Model / Reference
PP02.000.040 EUDAMED

Identifiers

Primary DI / UDI-DI
08800069204157 EUDAMED
Basic UDI-DI
880926429PP38 EUDAMED
Direct Marketing DI
08800069204157 EUDAMED
EMDN Code
Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Germany 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

Paper Points by Sure Dent Corporation — 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

EUDAMED SRN
KR-MF-000018662
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (1)

  • EUDAMED f0592b75-44a0-41b0-96d6-21dc8a6ba8c7 61 fields · synced Jun 18, 2026