Identity
- Trade Name
- Endogal EDTA EUDAMED
- Device Name
- EDTA Solution for Root Canal Cleaning and Smear Layer Removal EUDAMED
- Model / Reference
- MD-Cleanser EUDAMED- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806387861317 EUDAMED
- Basic UDI-DI
- B-08806387861317 EUDAMED
- EMDN Code
- Q01010299 ROOT CANAL FILLING DEVICES - OTHER 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
Endogal EDTA by Meta Biomed Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-08806387861317 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Meta Biomed Co., Ltd.
- EUDAMED SRN
- KR-MF-000009681
- Authorised Representative
- Meta Biomed Europe GmbH DE-AR-000004953
Sources (1)
- EUDAMED e3729e64-9162-4bc6-968f-73583580c7bb 61 fields · synced Jul 25, 2026