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Wellsamed Paper Points
EUDAMEDClass IIa (EU MDR)
Ref WPP425 ISO25 RotRef WPP635 ISO35 GruenRef WPP601 ISO20-45 SortiertRef WPP330 ISO30 BlauRef WPP301 ISO15-40 SortiertRef WPP420 ISO20 GelbRef WPP345 ISO45 WeissRef WPP625 ISO25 RotRef WPP445 ISO45 WeissRef WPP620 ISO20 GelbRef WPP630 ISO30 BlauRef WPP380 ISO80 Schwarz
Identity
- Trade Name
- Wellsamed Paper Points EUDAMED
- Device Name
- Sterile Absorbent Paper Points EUDAMED
- Model / Reference
- WPP425 ISO25 Rot EUDAMEDWPP635 ISO35 Gruen EUDAMEDWPP601 ISO20-45 Sortiert EUDAMEDWPP330 ISO30 Blau EUDAMEDWPP301 ISO15-40 Sortiert EUDAMEDWPP420 ISO20 Gelb EUDAMEDWPP345 ISO45 Weiss EUDAMEDWPP625 ISO25 Rot EUDAMEDWPP445 ISO45 Weiss EUDAMEDWPP620 ISO20 Gelb EUDAMEDWPP630 ISO30 Blau EUDAMEDWPP380 ISO80 Schwarz EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069207301 EUDAMED08800069207400 EUDAMED08800069207431 EUDAMED08800069207172 EUDAMED08800069207264 EUDAMED08800069207295 EUDAMED08800069207202 EUDAMED08800069207387 EUDAMED08800069207349 EUDAMED08800069207370 EUDAMED08800069207394 EUDAMED08800069207257 EUDAMED
- Basic UDI-DI
- 880926429PP38 EUDAMED
- Direct Marketing DI
- 08800069207301 EUDAMED08800069207400 EUDAMED08800069207431 EUDAMED08800069207172 EUDAMED08800069207264 EUDAMED08800069207295 EUDAMED08800069207202 EUDAMED08800069207387 EUDAMED08800069207349 EUDAMED08800069207370 EUDAMED08800069207394 EUDAMED08800069207257 EUDAMED
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Wellsamed 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 5f36b512-ef8c-4728-8f44-93000b28b44c 61 fields · synced Sep 17, 2026
- EUDAMED d8bb0716-cf90-404a-8054-b2fb4a453497 61 fields · synced May 17, 2026
- EUDAMED 9144471e-5f37-40bd-855f-72412cc77ea8 61 fields · synced May 17, 2026
- EUDAMED 1eb1d02f-88ac-457d-b1b8-eb3402e507f5 61 fields · synced May 18, 2026
- EUDAMED 9fc898a7-54d6-4d09-839f-408ebacb0082 61 fields · synced May 18, 2026
- EUDAMED 961773c6-db05-455a-99e5-2c9e5f7c3061 61 fields · synced May 18, 2026
- EUDAMED 80ddc25c-51a7-4659-b09e-2527787818c7 61 fields · synced May 18, 2026
- EUDAMED b7c6e9a7-3ff0-40ba-b2da-f5a0a56e95ba 61 fields · synced May 18, 2026
- EUDAMED be9b32f9-80be-40d8-b544-3f1833f0cda3 61 fields · synced May 18, 2026
- EUDAMED 67a5a05a-08b8-4384-b14b-84b7fe266c93 61 fields · synced May 19, 2026
- EUDAMED b6725934-e061-4ef8-b977-e8cfe3631a83 61 fields · synced May 19, 2026
- EUDAMED c49fa4d5-78dd-4766-9184-7410682e7f71 61 fields · synced May 19, 2026