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Threadformer S3.5
EUDAMEDClass IIa (EU MDR)
Ref 2426.00Model Threadformer for guided surgery; Threadformer
by LASAK s.r.o.
Identity
- Trade Name
- Threadformer S3.5 EUDAMED
- Device Name
- BioniQ Instruments EUDAMED
- Model / Reference
- Threadformer for guided surgery; Threadformer EUDAMED2426.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573021818 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 S3.5 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 cea5984e-f23e-4e1e-9b9a-953c2da7c13d 61 fields · synced Jul 14, 2026