Identity
- Trade Name
- AHL Etch Gel 5ml Syringe + Tips EUDAMED
- Device Name
- Etch Gel Green / Blue EUDAMED
- Model / Reference
- OP071X1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056009107252 EUDAMED
- Basic UDI-DI
- 5056009120091SG EUDAMED
- EMDN Code
- Q01010402 ENAMEL-DENTINAL ETCHING MATERIALS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Malta 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
AHL Etch Gel 5ml Syringe + Tips by Advanced Healthcare Ltd. — 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 | 5056009120091SG | Class IIa | Active |
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Manufacturer
- Manufacturer
- Advanced Healthcare Ltd.
- EUDAMED SRN
- GB-MF-000002771
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED dd17eaf5-dfa9-4c53-b1a7-5493b5a6723d 61 fields · synced Jun 19, 2026