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Dentac Gutta Percha Points
EUDAMEDClass IIa (EU MDR)
Ref -Model Gutta Percha 06-LM-45/80
Identity
- Trade Name
- Dentac Gutta Percha Points EUDAMED
- Device Name
- Gutta Percha Points EUDAMED
- Model / Reference
- Gutta Percha 06-LM-45/80 EUDAMED- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806387811503 EUDAMED
- Basic UDI-DI
- B-08806387811503 EUDAMED
- EMDN Code
- Q01010203 DENTAL CONES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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
Dentac Gutta Percha Points 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-08806387811503 | 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 3ba6439d-0083-4099-8d51-bdfe5c9688e2 61 fields · synced Jul 8, 2026