Identity
- Trade Name
- VAROGuide Mini KIT EUDAMEDNeobiotech Implant System FDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Ver.00(R0) FDA UDI
- Model / Reference
- VAROGMKIT EUDAMEDFDA UDI
- Description
- Ver.00(R0) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809815653324 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809815653324 EUDAMED
- FDA Product Code
- DZA FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4130 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Neobiotech Implant System by Neobiotech. co., ltd — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Neobiotech. co., ltd
Sources (2)
- FDA UDI c37da4e9-6683-4c26-a3d3-9a4db1424c1e 33 fields · synced Jul 24, 2026
- EUDAMED 18a18e16-8827-4d89-a5ec-982845dc8690 61 fields · synced Jul 24, 2026