Identity
- Trade Name
- ACTILINK reborn EUDAMEDACTILINK™ FDA UDI
- Generic Name
- Plasma sterilizer FDA UDI
- Device Name
- Plasma Activator EUDAMEDThe ACTILINK reborn is a device intended for use in reducing carbon contamination level on dental implant surface by means of plasma enhanced vacuuming, in a chairside. FDA UDI
- Model / Reference
- ACTILINK EUDAMEDMD2-0069-00 EUDAMEDACTILINK reborn FDA UDI
- Description
- The ACTILINK reborn is a device intended for use in reducing carbon contamination level on dental implant surface by means of plasma enhanced vacuuming, in a chairside. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800066500269 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000665PLAATMEU2B EUDAMED
- Direct Marketing DI
- 08800066500269 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Plasma sterilizer FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Malta EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
ACTILINK reborn by Plasmapp 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 | 88000665PLAATMEU2B | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Plasmapp Co., Ltd
- EUDAMED SRN
- KR-MF-000012193
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 18e8850b-5fef-4b16-9946-09509e472aec 61 fields · synced Aug 4, 2026
- FDA UDI af9b9dd2-800c-4385-b13e-4296a63ff110 33 fields · synced May 29, 2026