Identity
- Trade Name
- Mega Etch EUDAMED
- Device Name
- 37% Phosphoric Acid Etching Gel EUDAMED
- Model / Reference
- Meta Etchant EUDAMED- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806387860594 EUDAMED
- Basic UDI-DI
- B-08806387860594 EUDAMED
- EMDN Code
- Q01010402 ENAMEL-DENTINAL ETCHING MATERIALS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Dental etching solution
Mega Etch by Meta Biomed Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental etching solution.
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- 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08806387860594 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Meta Biomed Co., Ltd.
- EUDAMED SRN
- KR-MF-000009681
- Authorised Representative
- Meta Biomed Europe GmbH DE-AR-000004953
Sources (1)
- EUDAMED c985a6ce-6ecc-4aef-ae5b-1dc10c69a269 61 fields · synced Jun 19, 2026