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i-system Impression Post
EUDAMEDClass I (EU MDR)
Ref I-SIP(3)Ref I-SIP(2.5)Ref I-SIPC(2.5)Ref I-SIPC(3)
by Novodent SA
Identity
- Trade Name
- i-system Impression Post EUDAMED
- Device Name
- Bone Level Mini Fixture Lab Analog EUDAMED
- Model / Reference
- I-SIP(3) EUDAMEDI-SIP(2.5) EUDAMEDI-SIPC(2.5) EUDAMEDI-SIPC(3) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630188200454 EUDAMED07630188200447 EUDAMED07630188202731 EUDAMED07630188202724 EUDAMED
- Basic UDI-DI
- 764016818003D7 EUDAMED
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
i-system Impression Post by Novodent SA — 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 | 764016818003D7 | Class I | Active |
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Manufacturer
- Manufacturer
- Novodent SA
- EUDAMED SRN
- CH-MF-000023309
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (4)
- EUDAMED 9a030bed-43fd-481c-a4f5-622e1604cba3 61 fields · synced Jul 25, 2026
- EUDAMED b96424be-017f-4751-8376-7afe65048c5e 61 fields · synced May 17, 2026
- EUDAMED 3525fb2d-95a5-4879-97ee-971daacac628 61 fields · synced May 17, 2026
- EUDAMED 0c749715-792d-42a2-b803-a705cfb98cdb 61 fields · synced May 18, 2026