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IT Oral Scan Body

EUDAMED

Class I (EU MDR)

Ref ITPSBS50PRef ITPSBO50WPRef ITPSBS50WPRef ITPSBO50OSWPRef ITPSBO50OSRP

by Neobiotech Co., Ltd.

Identity

Trade Name
IT Oral Scan Body EUDAMED
Device Name
Dental Surgical Instrument EUDAMED
Model / Reference
ITPSBS50P EUDAMED
ITPSBO50WP EUDAMED
ITPSBS50WP EUDAMED
ITPSBO50OSWP EUDAMED
ITPSBO50OSRP EUDAMED

Identifiers

Primary DI / UDI-DI
08800263101351 EUDAMED
08800263101320 EUDAMED
08800263101368 EUDAMED
08800263101344 EUDAMED
08800263101337 EUDAMED
Basic UDI-DI
880927676NBRSIRSCL1S03FT EUDAMED
EMDN Code
P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Poland EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

Yes

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

IT Oral Scan Body by Neobiotech Co., Ltd. — Class I — 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-000016946
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (5)

  • EUDAMED 1dacc5ca-409e-460c-9558-dfc0224f8907 61 fields · synced Jul 29, 2026
  • EUDAMED 82480971-0e26-419f-b3c8-cf6e54a1a213 61 fields · synced May 17, 2026
  • EUDAMED 4ff7d9fd-f365-4567-bff4-95c640bfe6ff 61 fields · synced May 18, 2026
  • EUDAMED eb1e3daa-0c33-433c-85ce-66cf2254d318 61 fields · synced May 19, 2026
  • EUDAMED 9f75b5fb-9cc0-474f-8962-6d4b5a34154d 61 fields · synced May 19, 2026