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Tru Dual Align Scan Body
EUDAMEDClass I (EU MDR)
Ref UR-DADW(6)Ref AT-DASB(6)Ref ST35-DASB(6)Ref ST46-DASB(6)Ref UR-DADW(12)Ref ST-DAW(12)Ref ST-DADW(6)Ref AT-DAW(12)Ref AT-DAW(6)Ref UR-DAW(12)Ref ST-DAW(6)Ref UR-DASB(12)Ref AT-DADW(6)
Identity
- Trade Name
- Tru Dual Align Scan Body EUDAMED
- Device Name
- Dental Scan Body Components (Individual) EUDAMED
- Model / Reference
- UR-DADW(6) EUDAMEDAT-DASB(6) EUDAMEDST35-DASB(6) EUDAMEDST46-DASB(6) EUDAMEDUR-DADW(12) EUDAMEDST-DAW(12) EUDAMEDST-DADW(6) EUDAMEDAT-DAW(12) EUDAMEDAT-DAW(6) EUDAMEDUR-DAW(12) EUDAMEDST-DAW(6) EUDAMEDUR-DASB(12) EUDAMEDAT-DADW(6) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800076473713 EUDAMED08800076473638 EUDAMED08800076473751 EUDAMED08800076473768 EUDAMED08800076473744 EUDAMED08800076473805 EUDAMED08800076473782 EUDAMED08800076473676 EUDAMED08800076473645 EUDAMED08800076473737 EUDAMED08800076473775 EUDAMED08800076473720 EUDAMED08800076473652 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
Tru Dual Align Scan Body 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 (13)
- EUDAMED 0a03ebe5-038f-47c0-8e2f-26536480099f 61 fields · synced Jul 30, 2026
- EUDAMED 3d1dbcc9-2ced-4515-8a38-49a656c4a298 61 fields · synced May 16, 2026
- EUDAMED 8de5704f-8424-49a7-b154-3e3032f64854 61 fields · synced May 16, 2026
- EUDAMED d8c16a00-25b7-43a9-a156-7bab2afd036b 61 fields · synced May 16, 2026
- EUDAMED 69381831-0724-4772-8661-98ff3f35f0c2 61 fields · synced May 17, 2026
- EUDAMED 4d5fa54f-d404-46e7-99f0-58905f691613 61 fields · synced May 17, 2026
- EUDAMED fe5665e8-2dfd-40c2-8895-408a06557076 61 fields · synced May 17, 2026
- EUDAMED 4e29d6dd-c3b4-4926-b2f9-4edf8df3b5a8 61 fields · synced May 18, 2026
- EUDAMED 6ba00ff9-0552-4628-8f53-bae04e735191 61 fields · synced May 18, 2026
- EUDAMED 4d388170-28f1-4c0e-81cf-d17326a3a0dd 61 fields · synced May 18, 2026
- EUDAMED b3f37f03-636d-44f4-941d-16763e4ed6a3 61 fields · synced May 18, 2026
- EUDAMED 0b9c2b5e-b1f7-418c-b703-2b8dd7bee505 61 fields · synced May 19, 2026
- EUDAMED da089409-bc23-4180-a498-022ef8d22887 61 fields · synced May 19, 2026