Identity
- Model / Reference
- MT-ACT5013C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800075200921 EUDAMED
- Basic UDI-DI
- B-08800075200921 EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
The MT-ACT5013C device is a medical device designed for the administration of medication, particularly in animal tissues. It has been identified as a Class IIb medical device and has undergone comprehensive testing to ensure its sterility and safety. The device's status indicates that it requires administrative approval before being placed on the market.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800075200921 | Class IIb | Active |
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Manufacturer
- Manufacturer
- I Do Biotech Co., Ltd
- EUDAMED SRN
- KR-MF-000022539
- Authorised Representative
- Valdent S.L. ES-AR-000022075
Sources (1)
- EUDAMED 219c587d-5322-4884-a1cf-8ad5c6195a19 61 fields · synced Aug 3, 2026