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Excellent Ball Impression Sheet
EUDAMEDClass I (EU MDR)
Ref S-EBIS
by Novodent SA
Identity
- Trade Name
- Excellent Ball Impression Sheet EUDAMED
- Device Name
- Bone Level Mini Fixture Lab Analog EUDAMED
- Model / Reference
- S-EBIS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630188201499 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
Excellent Ball Impression Sheet 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 (1)
- EUDAMED 90c73640-dd90-49ae-8a92-5d8d422b843d 61 fields · synced Jun 18, 2026