Identity
- Trade Name
- IS Non-Hex Pick-up Impression Coping EUDAMED
- Device Name
- Dental Surgical Instrument EUDAMED
- Model / Reference
- ISIPN711 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809876905172 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 Non-Hex Pick-up Impression Coping 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 (1)
- EUDAMED 7d0e1f35-9e33-4def-b0d9-825cc0c7d2a9 61 fields · synced Jun 17, 2026