← Back to catalogue
Apol® Pointes Gutta
EUDAMEDClass IIa (EU MDR)
Ref B55385Ref B55365Ref B55065Ref B55345Ref B55325Ref B55375
Identity
- Trade Name
- Apol® Pointes Gutta EUDAMED
- Device Name
- Gutta Percha Points EUDAMED
- Model / Reference
- B55385 EUDAMEDB55365 EUDAMEDB55065 EUDAMEDB55345 EUDAMEDB55325 EUDAMEDB55375 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069207585 EUDAMED08800069207561 EUDAMED08800069207479 EUDAMED08800069207547 EUDAMED08800069207523 EUDAMED08800069207578 EUDAMED
- Basic UDI-DI
- 880926429GP2D EUDAMED
- Direct Marketing DI
- 08800069207585 EUDAMED08800069207561 EUDAMED08800069207479 EUDAMED08800069207547 EUDAMED08800069207523 EUDAMED08800069207578 EUDAMED
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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
Apol® Pointes Gutta by Sure Dent Corporation — 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 | 880926429GP2D | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sure Dent Corporation
- EUDAMED SRN
- KR-MF-000018662
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (6)
- EUDAMED f2b0aaad-0649-491b-985a-156bb5d3a201 61 fields · synced Sep 17, 2026
- EUDAMED ef74bd39-4dd8-4cde-b301-e91330e5d42e 61 fields · synced May 17, 2026
- EUDAMED ae791b9f-d47c-4af8-b278-6cc41a685535 61 fields · synced May 17, 2026
- EUDAMED e1f43725-2256-415b-b5b3-bad5e9827508 61 fields · synced May 17, 2026
- EUDAMED d8fc5dfb-0765-4275-882a-9d8fd8f54e20 61 fields · synced May 18, 2026
- EUDAMED e1914155-76b7-4f51-83b6-04ab21399ee0 61 fields · synced May 19, 2026