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Universal Analog
EUDAMEDFDA UDIClass I (EU MDR)
Ref CAD-UAOTS45Model CAD-UABBLB0
Identity
- Trade Name
- Universal Analog EUDAMEDBiodenta FDA UDI
- Generic Name
- Dental implant analog FDA UDI
- Device Name
- CAD-UABBLB0 EUDAMEDUniversal Analog Compatible with Osstem (Hiossen) TSIII Regular FDA UDI
- Model / Reference
- CAD-UABBLB0 EUDAMEDCAD-UAOTS45 EUDAMEDFDA UDI
- Description
- Universal Analog Compatible with Osstem (Hiossen) TSIII Regular FDA UDI
Identifiers
- Catalog Number
- CAD-UAOTS45 FDA UDI
- Primary DI / UDI-DI
- 07640169736124 EUDAMEDFDA UDI
- Basic UDI-DI
- 0764016973CADUAVZ EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant analog FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Czechia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Universal Analog by Biodenta Swiss AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0764016973CADUAVZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biodenta Swiss AG
- EUDAMED SRN
- CH-MF-000034374
- Authorised Representative
- MedNet EC-REP IIb GmbH DE-AR-000011192
Sources (2)
- EUDAMED eb70675e-3df7-4712-9120-6e6af774c1ad 61 fields · synced Jul 13, 2026
- FDA UDI fb1ef1b8-313d-4c13-84cf-9b6b45f7eb34 34 fields · synced May 30, 2026