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Scanbody, BioniQ, indexed – long
EUDAMEDClass I (EU MDR)
Ref 2840.00Model 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 copingRef 2815.00
by LASAK s.r.o.
Identity
- Trade Name
- Scanbody, BioniQ, indexed – 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 EUDAMED2840.00 EUDAMED2815.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573001568 EUDAMED08595573001575 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
Category: Dental implant suprastructure, temporary, preformed, single-use
Scanbody, BioniQ, indexed – long by LASAK s.r.o. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Retaining Screw for Digital Model Analog — ADIN DENTAL IMPLANT SYSTEMS LTD. · Class I
- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
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 (2)
- EUDAMED f9ffe389-b8b5-4c49-921f-130c581e3c8e 61 fields · synced Jul 11, 2026
- EUDAMED 177aa86c-93e2-4e6a-8bb8-323ecda2fe97 61 fields · synced May 17, 2026