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COMPONENTI PER PROTESI FISSA-Mis. bordo gengivale
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 008MBG
Identity
- Trade Name
- DIRECT TITANIUM ATTACHMENTS FDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Device Name
- COMPONENTI PER PROTESI FISSA-Mis. bordo gengivale EUDAMEDDISPOSABLE measurer devices FDA UDI
- Model / Reference
- 008MBG EUDAMEDCUFF HEIGHT MEASURER FDA UDI
- Description
- DISPOSABLE measurer devices FDA UDI
Identifiers
- Catalog Number
- 008MBG FDA UDI
- Primary DI / UDI-DI
- 08059224003429 EUDAMEDFDA UDI
- Basic UDI-DI
- 805804571MBGKZ EUDAMED
- FDA Product Code
- EIL FDA UDI
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Surgical instrument handle, non-torque-limiting FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Italy 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
Moist Heat or Steam Sterilization FDA UDI
COMPONENTI PER PROTESI FISSA-Mis. bordo gengivale by Rhein 83 S.r.l. — Class IIa — 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 | 805804571MBGKZ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Rhein 83 S.r.l.
- EUDAMED SRN
- IT-MF-000005998
Sources (2)
- EUDAMED 961275d8-2581-4518-a6cc-8cc15f0c3c80 61 fields · synced Jun 18, 2026
- FDA UDI a75b1686-be1b-440c-870d-62016351395a 34 fields · synced May 30, 2026