← Back to catalogue
IS Hex Transfer Impression Coping
EUDAMEDClass I (EU MDR)
Ref ISITHL711Ref ISITH711
Identity
- Trade Name
- IS Hex Transfer Impression Coping EUDAMED
- Device Name
- Dental Surgical Instrument EUDAMED
- Model / Reference
- ISITHL711 EUDAMEDISITH711 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809876905226 EUDAMED08809876905219 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 Hex Transfer 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 (2)
- EUDAMED 753f6ee0-441d-4109-a1b7-d8f8a5289649 61 fields · synced Aug 1, 2026
- EUDAMED 4810107c-1963-401d-8dc6-4799340137c6 61 fields · synced May 18, 2026