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Exotec Pointes Papier Absorbantes, ISO Color, ISO Taper
EUDAMEDClass IIa (EU MDR)
Ref EN02842Ref EN02845Ref EN02843Ref EN02820Ref EN02861Ref EN02864Ref EN02830Ref EN02825
Identity
- Trade Name
- Exotec Pointes Papier Absorbantes, ISO Color, ISO Taper EUDAMED
- Device Name
- Sterile Absorbent Paper Points EUDAMED
- Model / Reference
- EN02842 EUDAMEDEN02845 EUDAMEDEN02843 EUDAMEDEN02820 EUDAMEDEN02861 EUDAMEDEN02864 EUDAMEDEN02830 EUDAMEDEN02825 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069211001 EUDAMED08800069211032 EUDAMED08800069211018 EUDAMED08800069210967 EUDAMED08800069211049 EUDAMED08800069211070 EUDAMED08800069210981 EUDAMED08800069210974 EUDAMED
- Basic UDI-DI
- 880926429PP38 EUDAMED
- Direct Marketing DI
- 08800069211001 EUDAMED08800069211032 EUDAMED08800069211018 EUDAMED08800069210967 EUDAMED08800069211049 EUDAMED08800069211070 EUDAMED08800069210981 EUDAMED08800069210974 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
Yes
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
Exotec Pointes Papier Absorbantes, ISO Color, ISO Taper 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 | 880926429PP38 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sure Dent Corporation
- EUDAMED SRN
- KR-MF-000018662
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (8)
- EUDAMED 83b381ab-455d-4abc-a898-3140ea9a6684 61 fields · synced Jul 17, 2026
- EUDAMED e47bf061-e0f4-4756-aa53-ff651493fddc 61 fields · synced May 16, 2026
- EUDAMED 1c924c21-8875-4e0b-995c-eed0a31f6d9f 61 fields · synced May 17, 2026
- EUDAMED d0c65333-8e28-4cc1-884b-9e0df7b0a6dd 61 fields · synced May 17, 2026
- EUDAMED 304ca909-3cfe-4b3c-b506-2a317af37865 61 fields · synced May 17, 2026
- EUDAMED 7aaae347-ec73-46ce-b987-c175187bf596 61 fields · synced May 18, 2026
- EUDAMED 45a735c4-d323-4b0d-ae4c-a18fe04b9e3a 61 fields · synced May 18, 2026
- EUDAMED 4cd5392a-90f8-4e42-8aa1-1a2c48ca141f 61 fields · synced May 18, 2026