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Gingiva former – bridge
EUDAMEDClass IIa (EU MDR)
Ref 2116.06Model Gingiva formerRef 2116.10Ref 2116.08
by LASAK s.r.o.
Identity
- Trade Name
- Gingiva former – bridge EUDAMED
- Device Name
- BioniQ Prosthetic components EUDAMED
- Model / Reference
- Gingiva former EUDAMED2116.06 EUDAMED2116.10 EUDAMED2116.08 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573014933 EUDAMED08595573023102 EUDAMED08595573023096 EUDAMED
- Basic UDI-DI
- 85955730034XZ EUDAMED
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Gingiva former – bridge 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 | 85955730034XZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- LASAK s.r.o.
- EUDAMED SRN
- CZ-MF-000031907
Sources (3)
- EUDAMED 41f33a46-05c4-48d5-8b54-f3046211164a 61 fields · synced Aug 4, 2026
- EUDAMED abd5309b-4e9c-4f72-9a00-ffcb89d12bec 61 fields · synced May 17, 2026
- EUDAMED e01b5826-9c6f-44aa-b399-b1f336e21714 61 fields · synced May 17, 2026