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T-Marker
EUDAMEDClass I (EU MDR)
Ref TM-UR10Ref TM-AT01Ref TM-AT09Ref TM-ST4610Ref TM-ST4605Ref TM-UR08Ref TM-ST3502Ref TM-ST4601Ref TM-ST3501Ref TM-UR04Ref TM-AT10Ref TM-ST4608Ref TM-ST4603Ref TM-ST4604Ref TM-ST4609Ref TM-AT02Ref TM-UR02
Identity
- Trade Name
- T-Marker EUDAMED
- Device Name
- Dental Scan Body Components (Individual) EUDAMED
- Model / Reference
- TM-UR10 EUDAMEDTM-AT01 EUDAMEDTM-AT09 EUDAMEDTM-ST4610 EUDAMEDTM-ST4605 EUDAMEDTM-UR08 EUDAMEDTM-ST3502 EUDAMEDTM-ST4601 EUDAMEDTM-ST3501 EUDAMEDTM-UR04 EUDAMEDTM-AT10 EUDAMEDTM-ST4608 EUDAMEDTM-ST4603 EUDAMEDTM-ST4604 EUDAMEDTM-ST4609 EUDAMEDTM-AT02 EUDAMEDTM-UR02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800076474109 EUDAMED08800076473911 EUDAMED08800076473997 EUDAMED08800076474222 EUDAMED08800076474178 EUDAMED08800076474086 EUDAMED08800076474123 EUDAMED08800076474130 EUDAMED08800076474116 EUDAMED08800076474048 EUDAMED08800076474000 EUDAMED08800076474208 EUDAMED08800076474154 EUDAMED08800076474161 EUDAMED08800076474215 EUDAMED08800076473928 EUDAMED08800076474024 EUDAMED
- Basic UDI-DI
- 88000764SBRYY 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 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 | 88000764SBRYY | 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 (17)
- EUDAMED 7e296f64-29e0-4be4-8472-85ee14db3d8f 61 fields · synced Aug 3, 2026
- EUDAMED b77a38e1-4d44-470f-815f-1267ff9472f1 61 fields · synced May 17, 2026
- EUDAMED e1e2f8bf-0bf3-43bc-be34-6455a69da32c 61 fields · synced May 17, 2026
- EUDAMED 97818e5b-7e93-4ac9-af41-12f95c091646 61 fields · synced May 17, 2026
- EUDAMED 62df8fa0-8df0-4325-beb7-386058e00b47 61 fields · synced May 18, 2026
- EUDAMED 4484c477-0dd7-41df-a69e-4c15f95097f1 61 fields · synced May 18, 2026
- EUDAMED 969d66dc-b61e-4a03-9950-2fbca8dd5f3c 61 fields · synced May 18, 2026
- EUDAMED b66ec0af-daf2-4a9d-9879-ca964f242797 61 fields · synced May 18, 2026
- EUDAMED c63f0ebf-aff7-44ee-812a-1210f00a5fae 61 fields · synced May 18, 2026
- EUDAMED 5c7ba7e7-346e-41b5-a929-de2dc3640f7c 61 fields · synced May 18, 2026
- EUDAMED 7b284ee5-882e-49f6-b41d-adccb25971b6 61 fields · synced May 18, 2026
- EUDAMED 1069d0c4-34a0-4050-9025-53b46ced62ef 61 fields · synced May 18, 2026
- EUDAMED d1cbabd2-b662-4403-ac5b-1d9a9178f6d2 61 fields · synced May 18, 2026
- EUDAMED 6a9bf84b-b67e-4609-a0e3-13bdc353bdb2 61 fields · synced May 18, 2026
- EUDAMED 3beb38d7-0980-4de0-ac41-dec5ce90f23a 61 fields · synced May 18, 2026
- EUDAMED aca26622-6c24-4c30-9ae7-c8c288975982 61 fields · synced May 18, 2026
- EUDAMED 645fe319-4a04-41a7-a155-f9d6d5448856 61 fields · synced May 19, 2026