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i-system Fixture
EUDAMEDClass IIb (EU MDR)
Ref I-SF5506(3)Ref I-SF4008(3)Ref I-SF6008(3)Ref I-SF4506(3)Ref I-SF4006(3)Ref I-SFD(2)Ref I-SF6004(3)Ref I-SFD(3)Ref I-SF5006(3)Ref I-SF3508(2)Ref I-SF4010(3)Ref I-SFD(2.5)Ref I-SF4508(2.5)Ref I-SCL(2)Ref I-SF4505(2.5)Ref I-SF3510(2)Ref I-SF5005(3)Ref I-SCL(2.5)Ref I-SF4006(2.5)Ref I-SCL(3)Ref I-SF4505(3)Ref I-SF4506(2.5)
by Novodent SA
Identity
- Trade Name
- i-system Fixture EUDAMEDi-system Fixture Cover Plug EUDAMED
- Device Name
- i-system Fixture EUDAMEDi-system Fixture Cover Plug EUDAMED
- Model / Reference
- I-SF5506(3) EUDAMEDI-SF4008(3) EUDAMEDI-SF6008(3) EUDAMEDI-SF4506(3) EUDAMEDI-SF4006(3) EUDAMEDI-SFD(2) EUDAMEDI-SF6004(3) EUDAMEDI-SFD(3) EUDAMEDI-SF5006(3) EUDAMEDI-SF3508(2) EUDAMEDI-SF4010(3) EUDAMEDI-SFD(2.5) EUDAMEDI-SF4508(2.5) EUDAMEDI-SCL(2) EUDAMEDI-SF4505(2.5) EUDAMEDI-SF3510(2) EUDAMEDI-SF5005(3) EUDAMEDI-SCL(2.5) EUDAMEDI-SF4006(2.5) EUDAMEDI-SCL(3) EUDAMEDI-SF4505(3) EUDAMEDI-SF4506(2.5) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640168184841 EUDAMED07640168184711 EUDAMED07640168184896 EUDAMED07640168184742 EUDAMED07640168184704 EUDAMED07630188202281 EUDAMED07640168184865 EUDAMED07630188202304 EUDAMED07640168184797 EUDAMED07640168184605 EUDAMED07640168184728 EUDAMED07630188202298 EUDAMED07640168184681 EUDAMED07630188206425 EUDAMED07640168184667 EUDAMED07640168184612 EUDAMED07640168184780 EUDAMED07630188206432 EUDAMED07640168184636 EUDAMED07630188206449 EUDAMED07640168184735 EUDAMED07640168184674 EUDAMED
- Basic UDI-DI
- B-07640168184841 EUDAMEDB-07640168184711 EUDAMEDB-07640168184896 EUDAMEDB-07640168184742 EUDAMEDB-07640168184704 EUDAMEDB-07630188202281 EUDAMEDB-07640168184865 EUDAMEDB-07630188202304 EUDAMEDB-07640168184797 EUDAMEDB-07640168184605 EUDAMEDB-07640168184728 EUDAMEDB-07630188202298 EUDAMEDB-07640168184681 EUDAMEDB-07630188206425 EUDAMEDB-07640168184667 EUDAMEDB-07640168184612 EUDAMEDB-07640168184780 EUDAMEDB-07630188206432 EUDAMEDB-07640168184636 EUDAMEDB-07630188206449 EUDAMEDB-07640168184735 EUDAMEDB-07640168184674 EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMEDP01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMEDTürkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
Implantable
Yes
EUDAMEDEUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
i-system Fixture by Novodent SA — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07640168184841 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Novodent SA
- EUDAMED SRN
- CH-MF-000023309
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (22)
- EUDAMED 87ca3f80-f0d7-4895-bb3a-70f8931a8c49 61 fields · synced Aug 4, 2026
- EUDAMED 4f6efa3a-5a61-4116-9ad1-c52eb426bb07 61 fields · synced May 16, 2026
- EUDAMED 2567da1a-cc5b-442a-8e2b-d37dac7f790c 61 fields · synced May 16, 2026
- EUDAMED 07da3fff-0913-470a-9813-14b8c803cb02 61 fields · synced May 17, 2026
- EUDAMED 695f5de9-67e4-4e12-aec8-5b0d39992032 61 fields · synced May 17, 2026
- EUDAMED 87da1043-77d4-459a-ab3c-f792da55b963 61 fields · synced May 17, 2026
- EUDAMED 86454955-0664-4226-8491-4c52f0ec47da 61 fields · synced May 17, 2026
- EUDAMED 39658770-fa89-473e-8d45-edf62356e125 61 fields · synced May 17, 2026
- EUDAMED 2368f7d0-7c4e-4698-be81-93a0520b4e90 61 fields · synced May 17, 2026
- EUDAMED 8a3c1c96-ad0e-4f4e-8bfe-db88191ad19f 61 fields · synced May 18, 2026
- EUDAMED db7b098d-6d05-406a-a6db-6de5e30576fe 61 fields · synced May 18, 2026
- EUDAMED e7ff8c68-fac2-439a-ab73-95db15ddc5ce 61 fields · synced May 18, 2026
- EUDAMED b1aecc40-4e06-4631-a40b-cfc49770191d 61 fields · synced May 18, 2026
- EUDAMED 82ec2567-f7bb-4dc9-adb4-63eb20f008cc 61 fields · synced May 18, 2026
- EUDAMED cc7fcb4e-0214-40c8-a303-cdec86203be5 61 fields · synced May 18, 2026
- EUDAMED 70b16e37-3cb4-43f6-abef-15475dc68f16 61 fields · synced May 18, 2026
- EUDAMED 480c2a2c-f958-42b9-b22c-769d9dc7dd97 61 fields · synced May 18, 2026
- EUDAMED d41a8a50-9c28-4937-b402-fc75d6ce44cd 61 fields · synced May 18, 2026
- EUDAMED 6923deaa-6db6-46c1-a38c-fdd765f1d6df 61 fields · synced May 18, 2026
- EUDAMED cf3b4104-edc5-4f2c-be31-5c1c77482b9a 61 fields · synced May 18, 2026
- EUDAMED ee7c2b5b-af37-4b62-8f51-104713cfacad 61 fields · synced May 19, 2026
- EUDAMED 7842adf5-aa61-4a57-a12b-204b6749fc66 61 fields · synced May 19, 2026