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Paper Points PRED Pointes de papier sterile
EUDAMEDClass IIa (EU MDR)
Ref 67121Ref 67124Ref 67105Ref 67104Ref 67128Ref 67103Ref 67106Ref 67129
Identity
- Trade Name
- Paper Points PRED Pointes de papier sterile EUDAMED
- Device Name
- Sterile Absorbent Paper Points EUDAMED
- Model / Reference
- 67121 EUDAMED67124 EUDAMED67105 EUDAMED67104 EUDAMED67128 EUDAMED67103 EUDAMED67106 EUDAMED67129 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069208056 EUDAMED08800069208094 EUDAMED08800069208162 EUDAMED08800069208155 EUDAMED08800069208186 EUDAMED08800069208148 EUDAMED08800069208100 EUDAMED08800069208193 EUDAMED
- Basic UDI-DI
- 880926429PP38 EUDAMED
- Direct Marketing DI
- 08800069208056 EUDAMED08800069208094 EUDAMED08800069208162 EUDAMED08800069208155 EUDAMED08800069208186 EUDAMED08800069208148 EUDAMED08800069208100 EUDAMED08800069208193 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
Paper Points PRED Pointes de papier sterile 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 7e8d4364-8975-4f7e-8448-802e5e642450 61 fields · synced Aug 4, 2026
- EUDAMED 9199a18b-0eea-4500-aaf6-ec085c8e406e 61 fields · synced May 11, 2026
- EUDAMED 73a64d2b-1a5a-4e9d-adc4-4cd5fc0825f4 61 fields · synced May 16, 2026
- EUDAMED 7cdf4efb-c5f4-4f03-a8b9-61a5ac91c44e 61 fields · synced May 18, 2026
- EUDAMED 370e6551-66c9-43dc-aae5-8e6a342316a2 61 fields · synced May 18, 2026
- EUDAMED 545e3a4e-545b-4242-beba-c5fd5098cf12 61 fields · synced May 19, 2026
- EUDAMED ed223fbd-cb56-4748-8464-5e9e33aecd17 61 fields · synced May 19, 2026
- EUDAMED b5264756-650f-4c6b-b116-3d84ca03a0fe 61 fields · synced May 19, 2026