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G-Etch
EUDAMEDClass IIa (EU MDR)
Ref JKV-50Model G-ETCHRef JKB-50Ref ETG-16Ref JRV-50Ref MET-6
by G-Pharma
Identity
- Trade Name
- G-ETCH EUDAMED
- Device Name
- Etching gel EUDAMED
- Model / Reference
- G-ETCH EUDAMEDJKV-50 EUDAMEDJKB-50 EUDAMEDETG-16 EUDAMEDJRV-50 EUDAMEDMET-6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03664933000710 EUDAMED03664933000703 EUDAMED03664933001878 EUDAMED03664933000734 EUDAMED03664933000741 EUDAMED
- Basic UDI-DI
- 3664933ETC01VH EUDAMED
- EMDN Code
- Q01010402 ENAMEL-DENTINAL ETCHING MATERIALS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMEDFrance 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
G-Etch by G-Pharma — 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 | 3664933ETC01VH | Class IIa | Active |
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Manufacturer
- Manufacturer
- G-Pharma
- EUDAMED SRN
- FR-MF-000017094
Sources (5)
- EUDAMED 81dcfe09-7958-44c1-9606-d620e1ff8ccd 61 fields · synced Aug 4, 2026
- EUDAMED 6d31e7b9-994c-41e4-a073-2f8e4e6af26b 61 fields · synced May 18, 2026
- EUDAMED dfb2b75c-5ddf-456e-886a-ac80ed2ca2b3 61 fields · synced Jun 20, 2026
- EUDAMED 0e38a349-27be-4b03-b57e-61c722b18a55 61 fields · synced Jun 20, 2026
- EUDAMED 6029658c-1c84-4f55-8910-83d61222edf3 61 fields · synced Jul 11, 2026