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Easyinsmile
EUDAMEDClass I (EU MDR)
Ref E1ZD210301LSOUModel EASYDO Finder-L1066 / EASYDO Finder-L1088Ref 4201001Model Sliced typeRef E2GM240101LOUModel Agent-L; Agent-M; Agent-HRef E2GM210501HSOUModel Easydo Activator M1082 / Easydo Activator Mini OneRef 9401001Model N4/C4/N6/C6/Small/small with ledge/Medium/Medium with ledge/Large/Large with ledge Ref 11GGCX3003Model X-TAPER,G3-PRO ,GOLD,X-ONE,X3,X-CORN,X-PRO GOLD,X-RECIPORC, X-RETREATMENT,X-TWO-S,X-ULTRASONIC,X-BABY,X3-MAX,X-PATH, K FILE,H-FILE,R-FILE, S-FILE,C-FILERef E2LA220501OUModel Light PDT 630, Light PDT B
Identity
- Trade Name
- Easyinsmile EUDAMED
- Device Name
- Implant Detector EUDAMEDLight PDT Agent EUDAMEDEasydo Activator EUDAMEDDental Matrix EUDAMEDEndodontic file EUDAMEDOral photodynamic therapy device EUDAMED
- Model / Reference
- EASYDO Finder-L1066 / EASYDO Finder-L1088 EUDAMEDE1ZD210301LSOU EUDAMEDSliced type EUDAMED4201001 EUDAMEDAgent-L; Agent-M; Agent-H EUDAMEDE2GM240101LOU EUDAMEDEasydo Activator M1082 / Easydo Activator Mini One EUDAMEDE2GM210501HSOU EUDAMEDN4/C4/N6/C6/Small/small with ledge/Medium/Medium with ledge/Large/Large with ledge EUDAMED9401001 EUDAMEDX-TAPER,G3-PRO ,GOLD,X-ONE,X3,X-CORN,X-PRO GOLD,X-RECIPORC, X-RETREATMENT,X-TWO-S,X-ULTRASONIC,X-BABY,X3-MAX,X-PATH, K FILE,H-FILE,R-FILE, S-FILE,C-FILE EUDAMED11GGCX3003 EUDAMEDLight PDT 630, Light PDT B EUDAMEDE2LA220501OU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977331330059 EUDAMED06977331330066 EUDAMED06977331330011 EUDAMED06977331330042 EUDAMED06977331330073 EUDAMED06977331330080 EUDAMED06977331330004 EUDAMED
- Basic UDI-DI
- 697733133EASYDOFinder9F EUDAMED697733133SlicedtypeFM EUDAMED697733133LightPDTAgentEM EUDAMED697733133EasydoE8 EUDAMED697733133NMediumLedgeP9 EUDAMED697733133XG3X3KHRSCJJ EUDAMED697733133Oralphoto6G EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMEDQ010499 ORTHODONTIC DEVICES - OTHER EUDAMEDQ010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMEDQ010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMEDNetherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMEDEUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMEDEUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMEDEUDAMED
Measuring Function
Yes
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Easyinsmile by Changsha Easyinsmile Intelligence Technology Co., Ltd. — Class I — 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 | 697733133EASYDOFinder9F | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000031446
- Authorised Representative
- R Sight B.V. NL-AR-000010445
Sources (7)
- EUDAMED acb1b7f5-926e-4c49-bf2f-cfd79baf3192 61 fields · synced Sep 17, 2026
- EUDAMED 7f443a74-81b3-4ffc-8fde-bb906d2d2cbf 61 fields · synced May 16, 2026
- EUDAMED 285cb340-fc93-481e-bc49-4bd4b594040b 61 fields · synced May 16, 2026
- EUDAMED c8274981-d0aa-4706-8566-dddc55d65f91 61 fields · synced May 16, 2026
- EUDAMED e20d87ab-c2e9-46c5-883f-47788ea1e127 61 fields · synced May 18, 2026
- EUDAMED 086baaf5-ed05-4f12-b0f6-3c3c1dd2f35d 61 fields · synced May 18, 2026
- EUDAMED cca2c41b-f67e-41e0-9e3d-54617ec358fd 61 fields · synced May 18, 2026