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Scanbody
EUDAMEDClass I (EU MDR)
Ref 21.333.35.127Model ScanbodyRef 21.710.34.000Ref 21.848.30.000Ref SMTL1903HRef 21.863.00.000Ref 21.712.45.000Ref 22.302.65.000Ref 21.405.00.000Ref 21.336.33.147Ref SMBL1902HRef 21.971.55.000Ref 22.545.36.000Ref 21.711.38.000Ref 22.751.00.000Ref 21.337.00.147Ref 21.850.00.000Ref 21.553.38.000Ref 21.552.33.000Ref 21.713.55.000Ref 22.743.41.001Ref 22.548.54.000Ref 21.555.50.000Ref 21.734.00.000Ref 21.403.30.000Ref 22.424.33.000
Identity
- Device Name
- Scanbody EUDAMED
- Model / Reference
- Scanbody EUDAMED21.333.35.127 EUDAMED21.710.34.000 EUDAMED21.848.30.000 EUDAMEDSMTL1903H EUDAMED21.863.00.000 EUDAMED21.712.45.000 EUDAMED22.302.65.000 EUDAMED21.405.00.000 EUDAMED21.336.33.147 EUDAMEDSMBL1902H EUDAMED21.971.55.000 EUDAMED22.545.36.000 EUDAMED21.711.38.000 EUDAMED22.751.00.000 EUDAMED21.337.00.147 EUDAMED21.850.00.000 EUDAMED21.553.38.000 EUDAMED21.552.33.000 EUDAMED21.713.55.000 EUDAMED22.743.41.001 EUDAMED22.548.54.000 EUDAMED21.555.50.000 EUDAMED21.734.00.000 EUDAMED21.403.30.000 EUDAMED22.424.33.000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251923101206 EUDAMED04251923103781 EUDAMED04251923107246 EUDAMED04251923112035 EUDAMED04251923109561 EUDAMED04251923103804 EUDAMED04251923104726 EUDAMED04251923102005 EUDAMED04251923101589 EUDAMED04251923112042 EUDAMED04251923107352 EUDAMED04251923104955 EUDAMED04251923103798 EUDAMED04251923109325 EUDAMED04251923101596 EUDAMED04251923107345 EUDAMED04251923102708 EUDAMED04251923102692 EUDAMED04251923103811 EUDAMED04251923105037 EUDAMED04251923104986 EUDAMED04251923102722 EUDAMED04251923103972 EUDAMED04251923101985 EUDAMED04251923107932 EUDAMED
- Basic UDI-DI
- 425192311931142154259K EUDAMED
- Direct Marketing DI
- 04251923101206 EUDAMED
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Scanbody by Heliocos GmbH — 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 | 425192311931142154259K | Class I | Active |
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Manufacturer
- Manufacturer
- Heliocos GmbH
- EUDAMED SRN
- DE-MF-000006272
Sources (26)
- EUDAMED 42a2391a-3aab-4a74-b5cf-8656787ee541 61 fields · synced Oct 6, 2026
- EUDAMED ee5d9ab6-e523-4c5f-aa59-b1b04db042da 61 fields · synced Jun 18, 2026
- EUDAMED b789c0d1-f784-48dc-9057-6dda14b4ba8e 61 fields · synced Jun 18, 2026
- EUDAMED 9bdfec8d-90cd-40f6-8137-7c14f265b5e2 61 fields · synced Jun 19, 2026
- EUDAMED 8892576d-1bdb-484b-be44-a43ad7d1158a 61 fields · synced Jul 9, 2026
- EUDAMED bf3263c3-5939-41c3-8dc3-76fd5d932fa4 61 fields · synced Jul 9, 2026
- EUDAMED 0d9dda8f-3eb4-4ba8-8b11-17a0975a1eb6 61 fields · synced Jul 9, 2026
- EUDAMED 3f62eef4-7261-424d-a568-5fc30dc66a8d 61 fields · synced Jul 9, 2026
- EUDAMED 60c6b244-eed7-407b-a5cc-f67f4550d1e9 61 fields · synced Jul 10, 2026
- EUDAMED 8399dab9-f5a0-498f-b2cc-d01e4f3cd56d 61 fields · synced Jul 10, 2026
- EUDAMED fdb7833b-ba6a-4fba-8649-88868d25b30e 61 fields · synced Jul 10, 2026
- EUDAMED babd3101-b0e5-4ff7-b7df-3310d119efa9 61 fields · synced Jul 12, 2026
- EUDAMED 1231b9ed-1114-4bdc-9e6d-1e243e7bafca 61 fields · synced Jul 13, 2026
- EUDAMED 929b3b1e-ae56-485b-b0d6-02183cb53fd7 61 fields · synced Jul 16, 2026
- EUDAMED 01acba24-9906-498e-8d83-25096473ba49 61 fields · synced Jul 16, 2026
- EUDAMED 893ac96e-9b0d-4832-aa31-4256aa5cb85b 61 fields · synced Jul 16, 2026
- EUDAMED 0e6aa168-3ab7-4af5-868d-78ba1e95519c 61 fields · synced Jul 17, 2026
- EUDAMED 79c5abb1-19a8-449d-8aa6-649a30fbed6a 61 fields · synced Jul 19, 2026
- EUDAMED 1f6a7343-5dcc-4bd9-9279-a3ddb1b7b160 61 fields · synced Jul 24, 2026
- EUDAMED 2f82917a-3020-40ef-a6bf-3b523b45fbf1 61 fields · synced Jul 24, 2026
- EUDAMED 9969857a-a09a-411f-9042-9d1aa827ad38 61 fields · synced Jul 25, 2026
- EUDAMED 9eb8a223-3bba-4538-8e9a-57c80a230eea 61 fields · synced Jul 26, 2026
- EUDAMED 2c7994ad-4798-4cfb-b3f8-908dc7fe2816 61 fields · synced Jul 28, 2026
- EUDAMED 310246e0-fef7-4412-8fc4-0c4324c9faa7 61 fields · synced Aug 1, 2026
- EUDAMED f5f1a8f3-f6a4-46ca-ba66-12cee467f407 61 fields · synced Aug 3, 2026
- EUDAMED f0864b37-58fa-4755-9596-325614f85958 61 fields · synced Sep 18, 2026