← Back to catalogue
Burnout NeoLink® Multi, NP - 2 pcs
EUDAMEDFDA UDIClass I (EU MDR)
Ref 31255
by Neoss AB
Identity
- Trade Name
- Burnout NeoLink® Multi, NP - 2 pcs EUDAMEDNeoss Implant System FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Burnout device EUDAMEDBurnout NeoLink Multi, NP - 2 pcs FDA UDI
- Model / Reference
- 31255 EUDAMEDFDA UDI
- Description
- Burnout NeoLink Multi, NP - 2 pcs FDA UDI
Identifiers
- Catalog Number
- 31255 FDA UDI
- Primary DI / UDI-DI
- 05060440331282 EUDAMEDFDA UDI
- Basic UDI-DI
- 506044033N0031MU 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
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Burnout NeoLink® Multi, NP - 2 pcs by Neoss AB — 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 | 506044033N0031MU | 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
- Neoss AB
- EUDAMED SRN
- SE-MF-000022321
Sources (2)
- EUDAMED eaa52758-f142-49b6-9f53-6fd81398fb2e 61 fields · synced Jun 19, 2026
- FDA UDI a4fdf6f7-6f92-4717-8e04-b1b10dba0019 34 fields · synced May 30, 2026