UniFit-Standard Internal Star Plastic Surgical Kit-Advanced
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- UniFit-Standard Internal Star Plastic Surgical Kit-Advanced EUDAMEDFDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
- Model / Reference
- Kit_2 EUDAMEDUF6322 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290109309439 EUDAMEDFDA UDI
- Basic UDI-DI
- 729010930FullKitKH EUDAMED
- FDA Product Code
- OFY FDA UDI
- EMDN Code
- L159016 DENTAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
- GMDN Term
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
UniFit-Standard Internal Star Plastic Surgical Kit-Advanced by Adin Dental Implant Systems Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 729010930FullKitKH | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Adin Dental Implant Systems LTD.
- EUDAMED SRN
- IL-MF-000014625
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 9c809bf9-93e6-4602-ac72-6bd5c3049abf 61 fields · synced Jul 13, 2026
- FDA UDI 1d7989a6-652f-43bf-87e2-a4d04a5fd167 32 fields · synced May 30, 2026