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Gingiva former – wide
EUDAMEDClass IIa (EU MDR)
Ref 2110.02Model Gingiva formerRef 2110.06Ref 2167.02Ref 2167.06Ref 2167.04Ref 2110.04Ref 2110.08Ref 2167.08
by LASAK s.r.o.
Identity
- Trade Name
- Gingiva former – wide EUDAMED
- Device Name
- BioniQ Prosthetic components EUDAMED
- Model / Reference
- Gingiva former EUDAMED2110.02 EUDAMED2110.06 EUDAMED2167.02 EUDAMED2167.06 EUDAMED2167.04 EUDAMED2110.04 EUDAMED2110.08 EUDAMED2167.08 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573014940 EUDAMED08595573014964 EUDAMED08595573014971 EUDAMED08595573014995 EUDAMED08595573014988 EUDAMED08595573014957 EUDAMED08595573023010 EUDAMED08595573022990 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 – wide 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 (8)
- EUDAMED a9b08d34-d2aa-4c7a-b66a-1c4e43fc25c0 61 fields · synced Jul 30, 2026
- EUDAMED 3159277d-cdf1-4538-b87f-2003ab0f10e3 61 fields · synced May 17, 2026
- EUDAMED 956740d8-8d4d-4af9-9878-e1f1721a218d 61 fields · synced May 17, 2026
- EUDAMED a3917bbb-9643-47b6-a78a-815bece8a973 61 fields · synced May 17, 2026
- EUDAMED f9d5123c-1ecc-4c1c-9807-c5510f6a0e81 61 fields · synced May 17, 2026
- EUDAMED 3fb8608b-1708-4f55-8e74-c9808cb98fc7 61 fields · synced May 18, 2026
- EUDAMED bd09606e-29a6-4258-b5dd-20e91b6f57e7 61 fields · synced May 18, 2026
- EUDAMED dfa572d0-7768-4995-9728-a27e3c24b023 61 fields · synced May 18, 2026