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PLS BioniQ – bridge support, CoCr
EUDAMEDClass IIb (EU MDR)
Ref 2161.20Model PLS BioniQ – bridge support, CoCr
by LASAK s.r.o.
Identity
- Trade Name
- PLS BioniQ – bridge support, CoCr EUDAMED
- Device Name
- BioniQ Prosthetic Components EUDAMED
- Model / Reference
- PLS BioniQ – bridge support, CoCr EUDAMED2161.20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573012410 EUDAMED
- Basic UDI-DI
- 85955730022XS 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
PLS BioniQ – bridge support, CoCr 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 | 85955730022XS | Class IIb | Active |
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Manufacturer
- Manufacturer
- LASAK s.r.o.
- EUDAMED SRN
- CZ-MF-000031907
Sources (1)
- EUDAMED 7ab9d0b0-83dd-4dd1-9378-0f3f0d6eb5ba 61 fields · synced Jun 18, 2026