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IS Lab Analog
EUDAMEDFDA UDIClass I (EU MDR)
Ref ISLA300Ref ISLA440Ref ISLA770Ref ISLA740
Identity
- Trade Name
- IS Lab Analog EUDAMEDNeobiotech Implant System FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Dental Surgical Instrument EUDAMEDØ6.5, L:7.0mm FDA UDI
- Model / Reference
- ISLA300 EUDAMEDISLA440 EUDAMEDISLA770 EUDAMEDFDA UDIISLA740 EUDAMED
- Description
- Ø6.5, L:7.0mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809876904809 EUDAMED08809876904847 EUDAMED08809276769985 EUDAMEDFDA UDI08809876904878 EUDAMED
- Basic UDI-DI
- 880927676NBRSIRSCL1S03FT EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
IS Lab Analog 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 | 880927676NBRSIRSCL1S03FT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Neobiotech Co., Ltd.
- EUDAMED SRN
- KR-MF-000016946
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (5)
- EUDAMED 17d0aa48-40d8-4869-b4b2-623f03defd65 61 fields · synced Aug 1, 2026
- EUDAMED f7028d21-078c-479a-a907-695c15b5f4ea 61 fields · synced May 17, 2026
- EUDAMED 22ea9e3b-3dbe-4378-9676-27d077db03a8 61 fields · synced May 18, 2026
- EUDAMED f39ecfbd-2570-4d31-88b7-8abea5866ea4 61 fields · synced May 19, 2026
- FDA UDI 51a6a69b-4182-4073-907a-41389a9e0f8d 33 fields · synced May 30, 2026