Identity
- Trade Name
- All-in one Remover KIT EUDAMEDNeobiotech Implant System FDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Dental Surgical KIT EUDAMEDVer.00 (R0) FDA UDI
- Model / Reference
- AIORKIT EUDAMEDFDA UDI
- Description
- Ver.00 (R0) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800263100002 EUDAMEDFDA UDI
- Basic UDI-DI
- 880927676NBRSKRUCL1S04JD EUDAMED
- FDA Product Code
- DZA FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4130 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
All-in one Remover KIT by Neobiotech Co., Ltd. — 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 | 880927676NBRSKRUCL1S04JD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Neobiotech Co., Ltd.
- EUDAMED SRN
- KR-MF-000016946
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 0690c0f7-92d8-4c07-b2dc-c24cadbe1e3b 61 fields · synced Jun 17, 2026
- FDA UDI 50d27b4a-e81a-49ff-adc7-edf5fa9fdbb9 33 fields · synced May 30, 2026