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Threadformer S5.0/T5.0
EUDAMEDClass IIa (EU MDR)
Ref 2438.00Model Threadformer for guided surgery; Threadformer
by LASAK s.r.o.
Identity
- Trade Name
- Threadformer S5.0/T5.0 EUDAMED
- Device Name
- BioniQ Instruments EUDAMED
- Model / Reference
- Threadformer for guided surgery; Threadformer EUDAMED2438.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573021832 EUDAMED
- Basic UDI-DI
- 85955730039YB EUDAMED
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia 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
Threadformer S5.0/T5.0 by LASAK s.r.o. — Class IIa — 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 | 85955730039YB | Class IIa | Active |
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Manufacturer
- Manufacturer
- LASAK s.r.o.
- EUDAMED SRN
- CZ-MF-000031907
Sources (1)
- EUDAMED 39c235e1-a3e2-4891-a43b-35e752989c98 61 fields · synced Jun 18, 2026