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Gingiva former – extra wide
EUDAMEDClass IIa (EU MDR)
Ref 2111.06Model Gingiva former
by LASAK s.r.o.
Identity
- Trade Name
- Gingiva former – extra wide EUDAMED
- Device Name
- BioniQ Prosthetic components EUDAMED
- Model / Reference
- Gingiva former EUDAMED2111.06 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573014896 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 (1)
- EUDAMED 4a219ad2-a5f8-476e-bea2-2a53266c3607 61 fields · synced Jun 18, 2026