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Centra® Endo Paper
EUDAMEDClass IIa (EU MDR)
Ref SD53CRef SD5150Ref SD53FRef SD53MRef SD5170Ref SD5130Ref SD5145-80Ref SD53XCRef SD5115-40Ref SD5120Ref SD53XFRef SD5160Ref SD5140
Identity
- Trade Name
- Centra® Endo Paper EUDAMED
- Device Name
- Sterile Absorbent Paper Points EUDAMED
- Model / Reference
- SD53C EUDAMEDSD5150 EUDAMEDSD53F EUDAMEDSD53M EUDAMEDSD5170 EUDAMEDSD5130 EUDAMEDSD5145-80 EUDAMEDSD53XC EUDAMEDSD5115-40 EUDAMEDSD5120 EUDAMEDSD53XF EUDAMEDSD5160 EUDAMEDSD5140 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069201996 EUDAMED08800069201897 EUDAMED08800069201972 EUDAMED08800069201989 EUDAMED08800069201927 EUDAMED08800069201859 EUDAMED08800069201958 EUDAMED08800069202009 EUDAMED08800069201941 EUDAMED08800069201835 EUDAMED08800069201965 EUDAMED08800069201910 EUDAMED08800069201873 EUDAMED
- Basic UDI-DI
- 880926429PP38 EUDAMED
- Direct Marketing DI
- 08800069201996 EUDAMED08800069201897 EUDAMED08800069201972 EUDAMED08800069201989 EUDAMED08800069201927 EUDAMED08800069201859 EUDAMED08800069201958 EUDAMED08800069202009 EUDAMED08800069201941 EUDAMED08800069201835 EUDAMED08800069201965 EUDAMED08800069201910 EUDAMED08800069201873 EUDAMED
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Centra® Endo Paper 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 (13)
- EUDAMED a52dafc0-ecf0-40d6-974a-d9088dbcb166 61 fields · synced Aug 3, 2026
- EUDAMED 93317538-6ec7-4cb2-a231-103479d12f04 61 fields · synced May 16, 2026
- EUDAMED 4a586165-cf72-4dfe-8be9-15189619f69c 61 fields · synced May 16, 2026
- EUDAMED f0f69b6a-707f-4dbd-8295-b5be22575a2d 61 fields · synced May 16, 2026
- EUDAMED 26ec71fb-aa34-40ef-a6a7-efb95efd45cb 61 fields · synced May 17, 2026
- EUDAMED 2e3131ce-02d8-4c67-b171-b11d38975549 61 fields · synced May 17, 2026
- EUDAMED 2ff65744-abfa-4351-b95b-e06ec1b31a19 61 fields · synced May 17, 2026
- EUDAMED 3e22fd95-b409-4012-84a0-6ad5840b8e29 61 fields · synced May 18, 2026
- EUDAMED 9dc0075e-630b-415e-9e95-af554e290f92 61 fields · synced May 18, 2026
- EUDAMED 3e39df8c-e0f6-4d58-b338-5b1125a03771 61 fields · synced May 18, 2026
- EUDAMED 435f4232-7d90-414f-9d63-0db78e68df94 61 fields · synced May 18, 2026
- EUDAMED 28d90e93-caff-4cd0-b887-2b5eafe079b6 61 fields · synced May 18, 2026
- EUDAMED de5df670-50c3-4ada-85ba-b2940d7999d2 61 fields · synced May 19, 2026