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Direct Paper Points
EUDAMEDClass IIa (EU MDR)
Ref 200067Ref 200069Ref 200071Ref 200055Ref 200061Ref 200056Ref 200065Ref 200053Ref 200060Ref 200066Ref 200054Ref 200059
Identity
- Trade Name
- Direct Paper Points EUDAMED
- Device Name
- Sterile Absorbent Paper Points EUDAMED
- Model / Reference
- 200067 EUDAMED200069 EUDAMED200071 EUDAMED200055 EUDAMED200061 EUDAMED200056 EUDAMED200065 EUDAMED200053 EUDAMED200060 EUDAMED200066 EUDAMED200054 EUDAMED200059 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069206434 EUDAMED08800069206458 EUDAMED08800069206472 EUDAMED08800069206311 EUDAMED08800069206373 EUDAMED08800069206328 EUDAMED08800069206410 EUDAMED08800069206298 EUDAMED08800069206366 EUDAMED08800069206427 EUDAMED08800069206304 EUDAMED08800069206359 EUDAMED
- Basic UDI-DI
- 880926429PP38 EUDAMED
- Direct Marketing DI
- 08800069206434 EUDAMED08800069206458 EUDAMED08800069206472 EUDAMED08800069206311 EUDAMED08800069206373 EUDAMED08800069206328 EUDAMED08800069206298 EUDAMED08800069206366 EUDAMED08800069206427 EUDAMED08800069206304 EUDAMED08800069206359 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
Direct 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 (12)
- EUDAMED 50b1e394-36d0-452b-bf11-ddae1bf302b9 61 fields · synced Aug 3, 2026
- EUDAMED 4a71e8e6-67b9-495e-b6f6-b05056b69bcb 61 fields · synced May 17, 2026
- EUDAMED ddb19702-9f3b-4a21-ae76-18d1dbff7aea 61 fields · synced May 17, 2026
- EUDAMED ecb36f57-abe3-436f-a68b-a3fec0d404f1 61 fields · synced May 17, 2026
- EUDAMED 856f9dba-9167-42ed-900c-ea0f6b6a19e0 61 fields · synced May 17, 2026
- EUDAMED 70ffcf72-5e49-47eb-a981-26793b0d970e 61 fields · synced May 17, 2026
- EUDAMED d5f8501c-b681-4e6c-a18c-5686b537daab 61 fields · synced May 18, 2026
- EUDAMED 249ac6e7-229c-443f-b610-2d509fe85a26 61 fields · synced May 18, 2026
- EUDAMED 4252bc4d-2f15-46f6-86f8-e988f1f3c4de 61 fields · synced May 18, 2026
- EUDAMED ddb9e4ef-2c3e-4655-bff3-0b9b72fce475 61 fields · synced May 18, 2026
- EUDAMED 77cc4c2c-ad6e-4bb8-ab54-f3793836f178 61 fields · synced May 19, 2026
- EUDAMED 66a14e59-53e7-4093-a1da-14ede9104865 61 fields · synced May 19, 2026