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XP-4D ® Absorbent Paper Points
EUDAMEDClass IIa (EU MDR)
Ref 08.610.03.050.BCRef 08.610.03.020.BCRef 08.610.03.S30.BC
Identity
- Trade Name
- XP-4D ® Absorbent Paper Points EUDAMED
- Device Name
- Sterile Absorbent Paper Points EUDAMED
- Model / Reference
- 08.610.03.050.BC EUDAMED08.610.03.020.BC EUDAMED08.610.03.S30.BC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069204980 EUDAMED08800069204959 EUDAMED08800069204997 EUDAMED
- Basic UDI-DI
- 880926429PP38 EUDAMED
- Direct Marketing DI
- 08800069204980 EUDAMED08800069204959 EUDAMED08800069204997 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
XP-4D ® Absorbent Paper Points 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 (3)
- EUDAMED 3113c654-c8d9-40e3-88f6-0456c3b8ebe9 61 fields · synced Aug 3, 2026
- EUDAMED 89d03bd8-4453-4960-85cb-a17a67e95ff5 61 fields · synced May 11, 2026
- EUDAMED c8eedaae-7d4b-42bb-8d27-72633d5a939d 61 fields · synced May 18, 2026