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Scanbody, BioniQ, Screw-On – long
EUDAMEDClass I (EU MDR)
Ref 2835.00Model Closed tray impression post; Pin extension for open tray impression components; Scanbody, BioniQ; ScanPost CEREC; Screw-On closed tray impression coping; Screw-On open tray impression coping; STANDARD impression coping
by LASAK s.r.o.
Identity
- Trade Name
- Scanbody, BioniQ, Screw-On – long EUDAMED
- Device Name
- BioniQ Impression and Laboratory Components EUDAMED
- Model / Reference
- Closed tray impression post; Pin extension for open tray impression components; Scanbody, BioniQ; ScanPost CEREC; Screw-On closed tray impression coping; Screw-On open tray impression coping; STANDARD impression coping EUDAMED2835.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573001629 EUDAMED
- Basic UDI-DI
- 85955730007XW EUDAMED
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Scanbody, BioniQ, Screw-On – long by LASAK s.r.o. — 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 | 85955730007XW | Class I | Active |
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Manufacturer
- Manufacturer
- LASAK s.r.o.
- EUDAMED SRN
- CZ-MF-000031907
Sources (1)
- EUDAMED c6786fbb-6679-475e-b2ec-77238cb939f1 61 fields · synced Jul 10, 2026