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i-GEL N
EUDAMEDClass IIa (EU MDR)
Ref IGEGKRef IGEK3Ref IGES1Ref IGEK1Ref IGEG1Ref IGECPRef IGEGPRef IGEM1Ref IGE12GRef IGEK2
Identity
- Trade Name
- i-GEL N EUDAMED
- Device Name
- Phosphoric Acid Etching Gel EUDAMED
- Model / Reference
- IGEGK EUDAMEDIGEK3 EUDAMEDIGES1 EUDAMEDIGEK1 EUDAMEDIGEG1 EUDAMEDIGECP EUDAMEDIGEGP EUDAMEDIGEM1 EUDAMEDIGE12G EUDAMEDIGEK2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04772178003171 EUDAMED04772178008398 EUDAMED04772178006721 EUDAMED04772178009364 EUDAMED04772178009388 EUDAMED04772178009302 EUDAMED04772178009319 EUDAMED04772178009401 EUDAMED04772178009333 EUDAMED04772178009371 EUDAMED
- Basic UDI-DI
- 4772178ML02EW3 EUDAMED
- EMDN Code
- Q01010402 ENAMEL-DENTINAL ETCHING MATERIALS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Lithuania 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
i-GEL N 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
- DC Keramik Ätzgel — PRISMAN GmbH · Class I
- 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 (10)
- EUDAMED 86181353-0a34-469e-b913-2f84c8986f37 61 fields · synced Aug 5, 2026
- EUDAMED 14ed07e0-5600-417c-a053-9f734821ba7c 61 fields · synced May 18, 2026
- EUDAMED fa388c14-f43b-471d-aba9-ff328f366248 61 fields · synced May 19, 2026
- EUDAMED 78cd93e3-8447-4c33-8361-4bad10e3ce75 61 fields · synced Jun 18, 2026
- EUDAMED 40cf3de1-23b8-4543-b92b-a656a6f83c16 61 fields · synced Jun 18, 2026
- EUDAMED 1122457b-973e-41b5-9787-ce1fbdc37653 61 fields · synced Jul 11, 2026
- EUDAMED 0f51aa1f-4e1d-43fc-b71e-acfeb19dc2a4 61 fields · synced Jul 14, 2026
- EUDAMED c3036782-ca47-4d2d-88ec-d6a04fe3951d 61 fields · synced Jul 22, 2026
- EUDAMED 776c7868-95fc-4761-af5e-cf8a8573811c 61 fields · synced Jul 30, 2026
- EUDAMED 66c02b4d-2dc2-4a63-a5da-0a8daf919e9e 61 fields · synced Aug 5, 2026