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Gingiva former – narrow
EUDAMEDClass IIa (EU MDR)
Ref 2166.02Model Gingiva formerRef 2109.08Ref 2166.04Ref 2109.10Ref 2166.08
by LASAK s.r.o.
Identity
- Trade Name
- Gingiva former – narrow EUDAMED
- Device Name
- BioniQ Prosthetic components EUDAMED
- Model / Reference
- Gingiva former EUDAMED2166.02 EUDAMED2109.08 EUDAMED2166.04 EUDAMED2109.10 EUDAMED2166.08 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573015039 EUDAMED08595573022976 EUDAMED08595573015046 EUDAMED08595573022983 EUDAMED08595573022952 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 – narrow 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 (5)
- EUDAMED 17c14b93-78af-44dd-a05b-f62e22cfa1d1 61 fields · synced Aug 4, 2026
- EUDAMED da8342ad-445f-44fa-b78c-93a6d9f5aba1 61 fields · synced May 16, 2026
- EUDAMED 1df02005-d72b-4f54-b63d-32b8ced23a60 61 fields · synced May 16, 2026
- EUDAMED bb727004-5182-428d-93d3-49a92d8c7ff6 61 fields · synced May 18, 2026
- EUDAMED 4a7c14cc-46fc-4095-8455-1a4d8c91309c 61 fields · synced May 18, 2026