← Back to catalogue
IS Oral Scan Body
EUDAMEDClass I (EU MDR)
Ref ISPSBH40DMPRef ISPSBH40NBPRef ISPSBH50OSPRef ISPSBH40OSMPRef ISPSBS50NBP
Identity
- Trade Name
- IS Oral Scan Body EUDAMED
- Device Name
- Dental Surgical Instrument EUDAMED
- Model / Reference
- ISPSBH40DMP EUDAMEDISPSBH40NBP EUDAMEDISPSBH50OSP EUDAMEDISPSBH40OSMP EUDAMEDISPSBS50NBP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809876908821 EUDAMED08809876908777 EUDAMED08809876908814 EUDAMED08809876908791 EUDAMED08809876908852 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
IS 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880927676NBRSIRSCL1S03FT | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Neobiotech Co., Ltd.
- EUDAMED SRN
- KR-MF-000016946
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (5)
- EUDAMED 7801208c-f345-4c63-afb7-d7a73e32d1af 61 fields · synced Jul 23, 2026
- EUDAMED c0790bb4-9f49-4c5e-88ba-c4efc08880c9 61 fields · synced May 17, 2026
- EUDAMED fa1f0277-e169-4493-a715-51de0bdf6a35 61 fields · synced May 17, 2026
- EUDAMED f7c95d67-c8b2-4a79-bf4b-b8a2eaa599b9 61 fields · synced May 18, 2026
- EUDAMED f6795d54-e661-4112-8b07-04ef33094b68 61 fields · synced May 18, 2026