Identity
- Trade Name
- Elitis etch EUDAMED
- Device Name
- Phosphoric Acid Etching Gel EUDAMED
- Model / Reference
- QMSIGEM1 EUDAMEDQMSIGE12 EUDAMEDQMSIGE56B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04772178003294 EUDAMED04772178009500 EUDAMED04772178009531 EUDAMED04772178009494 EUDAMED
- Basic UDI-DI
- 4772178ML02EW3 EUDAMED
- EMDN Code
- Q01010402 ENAMEL-DENTINAL ETCHING MATERIALS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Portugal EUDAMEDLithuania 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
Category: Dental etching solution
Elitis etch by UAB "Medicinos linija" — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental etching solution.
- Dento-Etch — Spident · Class IIa
- Vivid TruEtch 10% Kit — PEARSON DENTAL SUPPLIES, INC. · Class II
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- MASTER-DENT — DENTONICS, INC.
- OSE 8oz. Orthodontic Etching Gel - Blue — ORTHODONTIC SUPPLY & EQUIPMENT CO., INC. · Class II
- ETCHANT — Pulpdent Corporation · Class II
- Scotchbond™ Universal — 3M Deutschland GmbH · Class II
- GC CERAMIC PRIMER II — Gc America Inc. · Class II
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 | 4772178ML02EW3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- UAB "Medicinos linija"
- EUDAMED SRN
- LT-MF-000002719
Sources (4)
- EUDAMED 15f6fcfa-6526-473c-ad68-000e3461ce33 61 fields · synced Jul 30, 2026
- EUDAMED cdb1009d-e262-435c-b385-3450a0e190b7 61 fields · synced Jun 18, 2026
- EUDAMED 8eeaaa8c-1521-4ace-b12b-5fe9013b78d4 61 fields · synced Jul 9, 2026
- EUDAMED fbffb1f6-1edc-4f96-9069-07dbe8b562fd 61 fields · synced Jul 30, 2026