Identity
- Trade Name
- T-Marker Kit EUDAMED
- Device Name
- T-Marker Kit EUDAMED
- Model / Reference
- TMK-UR EUDAMEDTMK-AT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800076474246 EUDAMED08800076474239 EUDAMED
- Basic UDI-DI
- 88000764TMKZQ EUDAMED
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
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
T-Marker Kit by TruAbutment Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88000764TMKZQ | Class I | Active |
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Manufacturer
- Manufacturer
- TruAbutment Inc.
- EUDAMED SRN
- US-MF-000043448
- Authorised Representative
- AeMi World e.K DE-AR-000007704
Sources (2)
- EUDAMED 7f5afb1f-0775-4eb9-b5a6-8733386bebd8 61 fields · synced Jul 31, 2026
- EUDAMED 3a294552-6aec-4390-92f0-07de1a9aa7ab 61 fields · synced May 19, 2026