← Back to catalogue
BioniQ implant – straight
EUDAMEDClass IIb (EU MDR)
Ref 2003.12Model BioniQ implant – straight, BioniQ implant – tapered, BioniQ implant Plus – straightRef 2003.10Ref 2026.14Ref 2009.14Ref 2006.10Ref 2006.14Ref 2028.10Ref 2027.08Ref 2017.16Ref 2003.14Ref 2017.12Ref 2017.10Ref 2029.14Ref 2017.06Ref 2009.10Ref 2009.08Ref 2009.12Ref 2029.12Ref 2028.12
by LASAK s.r.o.
Identity
- Trade Name
- BioniQ implant – straight EUDAMEDBioniQ implant Plus – straight EUDAMED
- Device Name
- BioniQ Dental Implants EUDAMED
- Model / Reference
- BioniQ implant – straight, BioniQ implant – tapered, BioniQ implant Plus – straight EUDAMED2003.12 EUDAMED2003.10 EUDAMED2026.14 EUDAMED2009.14 EUDAMED2006.10 EUDAMED2006.14 EUDAMED2028.10 EUDAMED2027.08 EUDAMED2017.16 EUDAMED2003.14 EUDAMED2017.12 EUDAMED2017.10 EUDAMED2029.14 EUDAMED2017.06 EUDAMED2009.10 EUDAMED2009.08 EUDAMED2009.12 EUDAMED2029.12 EUDAMED2028.12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573002558 EUDAMED08595573002541 EUDAMED08595573003210 EUDAMED08595573002794 EUDAMED08595573002626 EUDAMED08595573002640 EUDAMED08595573003289 EUDAMED08595573003227 EUDAMED08595573003043 EUDAMED08595573002565 EUDAMED08595573003029 EUDAMED08595573003012 EUDAMED08595573003357 EUDAMED08595573002992 EUDAMED08595573002770 EUDAMED08595573002763 EUDAMED08595573002787 EUDAMED08595573003340 EUDAMED08595573003296 EUDAMED
- Basic UDI-DI
- 85955730001XJ EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
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
BioniQ implant – straight by LASAK s.r.o. — Class IIb — 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 | 85955730001XJ | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- LASAK s.r.o.
- EUDAMED SRN
- CZ-MF-000031907
Sources (19)
- EUDAMED b08bd3c3-4eb3-4de5-b94c-2e51915ac56d 61 fields · synced Aug 2, 2026
- EUDAMED e15ed818-5981-43b1-b703-c515e512f97f 61 fields · synced May 17, 2026
- EUDAMED da1e1538-3b57-48e7-ae23-9e75ede70a7d 61 fields · synced May 17, 2026
- EUDAMED ba0deb73-a1f4-4693-b038-d406f52b262f 61 fields · synced May 17, 2026
- EUDAMED 14678779-f20c-4d67-8c11-957d571a265a 61 fields · synced May 17, 2026
- EUDAMED 75cf2842-80ea-41df-9342-7f7c7f7ae474 61 fields · synced May 17, 2026
- EUDAMED 3955bd9b-c4d6-44f7-ac32-45b47cf1417a 61 fields · synced May 17, 2026
- EUDAMED 9dc27856-d50d-4d46-97cd-3db6d67e7681 61 fields · synced May 17, 2026
- EUDAMED 5b4a59e7-52d6-4bf9-827a-86c07f8aa1a0 61 fields · synced May 18, 2026
- EUDAMED 23313e2f-b051-4d3f-89a7-678edbf16d57 61 fields · synced May 18, 2026
- EUDAMED 66b00ac1-aac0-4ea3-ac70-34adb2e471a3 61 fields · synced May 18, 2026
- EUDAMED 9bab8065-b671-46b1-9bfd-7dcb013f96eb 61 fields · synced May 18, 2026
- EUDAMED ace3c0f6-4eda-4cf8-addc-72ae5c6c53ac 61 fields · synced May 18, 2026
- EUDAMED a51c74b0-4209-4d0c-af96-cc95839b05c9 61 fields · synced May 18, 2026
- EUDAMED 4736f89e-4457-4b49-bfb9-f586f87371ab 61 fields · synced May 18, 2026
- EUDAMED c52bf077-bb91-4e4a-b312-3b1f24e95d04 61 fields · synced May 18, 2026
- EUDAMED 2dfea546-4df2-4282-8253-810dc2a70680 61 fields · synced May 18, 2026
- EUDAMED aa21f3f2-32d2-4957-a6c7-714056c45c17 61 fields · synced May 18, 2026
- EUDAMED d004a1e3-c600-4bb8-bfad-e79a1c06caa7 61 fields · synced May 19, 2026