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Countersink for guided surgery S5.0/T5.0 (GS)
EUDAMEDClass IIa (EU MDR)
Ref 2510.00Model Countersink for guided surgery; Countersink
by LASAK s.r.o.
Identity
- Trade Name
- Countersink for guided surgery S5.0/T5.0 (GS) EUDAMED
- Device Name
- BioniQ Instruments EUDAMED
- Model / Reference
- Countersink for guided surgery; Countersink EUDAMED2510.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573021511 EUDAMED
- Basic UDI-DI
- 85955730038Y9 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
Countersink for guided surgery S5.0/T5.0 (GS) 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 | 85955730038Y9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- LASAK s.r.o.
- EUDAMED SRN
- CZ-MF-000031907
Sources (1)
- EUDAMED 5305e6a6-1eb3-4c38-83de-4eea760fb13a 61 fields · synced Jul 14, 2026