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Gingiva former – extra wide
EUDAMEDClass IIa (EU MDR)
Ref 2111.10Model Gingiva formerRef 2259.10Ref 2111.08Ref 2111.04Ref 2259.06Ref 2259.08
by LASAK s.r.o.
Identity
- Trade Name
- Gingiva former – extra wide EUDAMEDGingiva former – extra wide, concave EUDAMED
- Device Name
- BioniQ Prosthetic components EUDAMED
- Model / Reference
- Gingiva former EUDAMED2111.10 EUDAMED2259.10 EUDAMED2111.08 EUDAMED2111.04 EUDAMED2259.06 EUDAMED2259.08 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573023041 EUDAMED08595573023089 EUDAMED08595573023034 EUDAMED08595573014889 EUDAMED08595573023065 EUDAMED08595573023072 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 – extra 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 (6)
- EUDAMED 7341c45b-86d4-4fe3-a563-2829757a841d 61 fields · synced Jul 30, 2026
- EUDAMED a5a1aa37-11ca-4439-9fe9-1ce4dd87e456 61 fields · synced May 17, 2026
- EUDAMED c1e91117-9891-4834-ae03-d3c7f0514de2 61 fields · synced May 18, 2026
- EUDAMED b0d451ba-ad64-4bb0-b8bd-be35f990e3c3 61 fields · synced May 18, 2026
- EUDAMED dd09d0d7-3145-4aa1-adb1-c29dde6fcb17 61 fields · synced May 18, 2026
- EUDAMED 19463173-fdb0-446f-87f0-248bc640fe20 61 fields · synced May 18, 2026