Identity
- Trade Name
- Analog Ø 5,0 EUDAMEDIPD FDA UDI
- Generic Name
- Dental implant analog FDA UDI
- Device Name
- Analogue EUDAMEDAnalog Ø 5,0 FDA UDI
- Model / Reference
- AN EUDAMEDFDA UDIIPD/BB-AW-00 EUDAMED
- Description
- Analog Ø 5,0 FDA UDI
Identifiers
- Catalog Number
- IPD/BB-AW-00 FDA UDI
- Primary DI / UDI-DI
- 08435566605017 EUDAMEDFDA UDI
- Basic UDI-DI
- 8435566615BX 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
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Analog Ø 5, 0 by Implant Protesis Dental 2004 S.l. — 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 | 8435566615BX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Implant Protesis Dental 2004 S.l.
- EUDAMED SRN
- ES-MF-000002195
Sources (2)
- EUDAMED 22f46884-9a1e-450a-b0cf-08f1cf36adfb 61 fields · synced Jul 9, 2026
- FDA UDI eb8bbeef-d538-4828-bd2d-d77062881c63 35 fields · synced May 30, 2026