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Omnibase AR 3.5 -CS Customizable
EUDAMEDClass IIb (EU MDR)
Ref 5923Model Tibase
Identity
- Trade Name
- Omnibase AR 3.5 -CS Customizable EUDAMED
- Model / Reference
- Tibase EUDAMED5923 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290120465169 EUDAMED
- Basic UDI-DI
- 729011781Tibase5D EUDAMED
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Omnibase AR 3.5 -CS Customizable by Alpha Bio Tec Ltd. — Class IIb — 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 | 729011781Tibase5D | Class IIb | Active |
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Manufacturer
- Manufacturer
- Alpha Bio Tec Ltd.
- EUDAMED SRN
- IL-MF-000021145
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 76abf7d8-4f69-42f5-be4e-88ca4f480b32 61 fields · synced Jun 19, 2026