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Surgical Guide IS Lab Analog
EUDAMEDClass I (EU MDR)
Ref SGISLA500Ref SGISLA400
Identity
- Trade Name
- Surgical Guide IS Lab Analog EUDAMED
- Device Name
- Dental Surgical Instrument EUDAMED
- Model / Reference
- SGISLA500 EUDAMEDSGISLA400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809876904854 EUDAMED08809876904823 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 Lab Analog 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 f58cc977-d2ac-4057-a6ca-a7a19b7f6538 61 fields · synced Jul 15, 2026
- EUDAMED cd457788-0180-4146-9812-8885b4390711 61 fields · synced May 17, 2026