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Surgical Guide IS Fixture Adapter_Screw
EUDAMEDClass I (EU MDR)
Ref SGISFASRef SGISFAS30
Identity
- Trade Name
- Surgical Guide IS Fixture Adapter_Screw EUDAMED
- Device Name
- Dental Surgical Instrument EUDAMED
- Model / Reference
- SGISFAS EUDAMEDSGISFAS30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800263100507 EUDAMED08809876905776 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
Surgical Guide IS Fixture Adapter_Screw 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 |
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Manufacturer
- Manufacturer
- Neobiotech Co., Ltd.
- EUDAMED SRN
- KR-MF-000016946
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 9d0d47cd-dc97-4cf2-972a-a988ed3c5e1b 61 fields · synced Jul 15, 2026
- EUDAMED de977688-0d51-4363-a86c-b9c76f298cfa 61 fields · synced May 17, 2026