Identity
- Trade Name
- IS SCRP Pick-up Impression Coping EUDAMEDNeobiotech Implant System FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Dental Surgical Instrument EUDAMEDø4.8, Long FDA UDI
- Model / Reference
- ISIPSL411 EUDAMEDFDA UDI
- Description
- ø4.8, Long FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809407155519 EUDAMEDFDA UDI
- 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 SCRP Pick-up Impression Coping 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 (2)
- EUDAMED 5fd9a712-fdd1-4893-8cd3-9a6b49729175 61 fields · synced Jul 18, 2026
- FDA UDI c5a48f3a-9338-4c7a-8af6-82c96e2b2cc5 33 fields · synced May 30, 2026