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Uni-Base AN, BioniQ, non-indexed, wide
EUDAMEDClass IIb (EU MDR)
Ref 2227.25Model Uni-Base, BioniQ; Uni-Base AN, BioniQRef 2211.25Ref 2211.15Ref 2213.35Ref 2211.35Ref 2215.07Ref 2213.07Ref 2235.07Ref 2235.15Ref 2220.15Ref 2227.35Ref 2215.25Ref 2220.07Ref 2235.25Ref 2213.25Ref 2220.35Ref 2215.15Ref 2219.35Ref 2227.07
by LASAK s.r.o.
Identity
- Trade Name
- Uni-Base AN, BioniQ, non-indexed, wide EUDAMEDUni-Base AN, BioniQ, indexed, wide EUDAMEDUni-Base, BioniQ, non-indexed, wide EUDAMED
- Device Name
- BioniQ Prosthetic Components EUDAMED
- Model / Reference
- Uni-Base, BioniQ; Uni-Base AN, BioniQ EUDAMED2227.25 EUDAMED2211.25 EUDAMED2211.15 EUDAMED2213.35 EUDAMED2211.35 EUDAMED2215.07 EUDAMED2213.07 EUDAMED2235.07 EUDAMED2235.15 EUDAMED2220.15 EUDAMED2227.35 EUDAMED2215.25 EUDAMED2220.07 EUDAMED2235.25 EUDAMED2213.25 EUDAMED2220.35 EUDAMED2215.15 EUDAMED2219.35 EUDAMED2227.07 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573022631 EUDAMED08595573022747 EUDAMED08595573022723 EUDAMED08595573014285 EUDAMED08595573022761 EUDAMED08595573022587 EUDAMED08595573014254 EUDAMED08595573014339 EUDAMED08595573014346 EUDAMED08595573014308 EUDAMED08595573022655 EUDAMED08595573022600 EUDAMED08595573014292 EUDAMED08595573014353 EUDAMED08595573014278 EUDAMED08595573014322 EUDAMED08595573022594 EUDAMED08595573022778 EUDAMED08595573022624 EUDAMED
- Basic UDI-DI
- 85955730026Y2 EUDAMED
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
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
Uni-Base AN, BioniQ, non-indexed, wide 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 | 85955730026Y2 | Class IIb | Active |
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Manufacturer
- Manufacturer
- LASAK s.r.o.
- EUDAMED SRN
- CZ-MF-000031907
Sources (19)
- EUDAMED 194581a8-b6d8-48a1-9193-25d17a011193 61 fields · synced Jul 31, 2026
- EUDAMED 515b1f67-ab1a-4d5c-99db-383015ce213a 61 fields · synced May 16, 2026
- EUDAMED 473df600-ea60-4b3d-9ef6-0e03a5704e28 61 fields · synced May 16, 2026
- EUDAMED 268f101f-c500-4039-a639-9118f8cdc0d8 61 fields · synced May 17, 2026
- EUDAMED 4bf9bd58-9b73-4643-951a-2c4618329f74 61 fields · synced May 17, 2026
- EUDAMED 9333ca46-6eb7-4974-ac56-240914c716e0 61 fields · synced May 17, 2026
- EUDAMED d3dda9b6-a61f-418c-8c51-496ab6c38daf 61 fields · synced May 17, 2026
- EUDAMED ea437ac3-ea80-47ba-97d7-6907cba3380e 61 fields · synced May 17, 2026
- EUDAMED 510d3ea2-7f5a-4bd4-9ca1-b5d7492f7e72 61 fields · synced May 17, 2026
- EUDAMED 2ba94700-2a2c-489c-9628-6391b8f656a4 61 fields · synced May 17, 2026
- EUDAMED 4aef8e6b-12f8-4571-aa7e-3b969d3b9d0c 61 fields · synced May 17, 2026
- EUDAMED 3c55bf82-7969-4c55-a635-a950bc82b7bd 61 fields · synced May 17, 2026
- EUDAMED 17413820-c313-40db-b673-b5a24467963e 61 fields · synced May 17, 2026
- EUDAMED c8950352-f87f-4aad-bb88-0444f4d32abb 61 fields · synced May 18, 2026
- EUDAMED 24de0a04-43a4-4543-8913-bbc58e98da72 61 fields · synced May 18, 2026
- EUDAMED 3c9c93c7-7885-4a4a-94d9-7d8fe035c7b4 61 fields · synced May 18, 2026
- EUDAMED 8147bff0-355f-4f3d-954a-6521403583cf 61 fields · synced May 18, 2026
- EUDAMED 101b449c-96c2-4224-99e1-cb043ae2dd69 61 fields · synced May 18, 2026
- EUDAMED 97886d79-97a3-4b47-b5f3-8c57f3aadb67 61 fields · synced May 19, 2026