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Acis
EUDAMEDClass IIa (EU MDR)
Ref 03.841.311Model Spine Trial Implants for ACISRef 03.841.007Ref 03.841.011Ref 03.841.411Ref 03.841.207Ref 03.841.105Ref 03.841.209Ref 03.841.205Ref 03.841.005Ref 03.841.405Ref 03.841.805Ref 03.841.611Ref 03.841.507Ref 03.841.505Ref 03.841.307Ref 03.841.705Ref 03.841.111Ref 03.841.211Ref 03.841.107Ref 03.841.511Ref 03.841.607Ref 03.841.109Ref 03.841.305
by Synthes GmbH
Identity
- Trade Name
- ACIS EUDAMED
- Device Name
- ACIS Trial Implant Small Standard Large Convex Parallel Lordotic EUDAMED
- Model / Reference
- Spine Trial Implants for ACIS EUDAMED03.841.311 EUDAMED03.841.007 EUDAMED03.841.011 EUDAMED03.841.411 EUDAMED03.841.207 EUDAMED03.841.105 EUDAMED03.841.209 EUDAMED03.841.205 EUDAMED03.841.005 EUDAMED03.841.405 EUDAMED03.841.805 EUDAMED03.841.611 EUDAMED03.841.507 EUDAMED03.841.505 EUDAMED03.841.307 EUDAMED03.841.705 EUDAMED03.841.111 EUDAMED03.841.211 EUDAMED03.841.107 EUDAMED03.841.511 EUDAMED03.841.607 EUDAMED03.841.109 EUDAMED03.841.305 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07611819473447 EUDAMED07611819473034 EUDAMED07611819473072 EUDAMED07611819473539 EUDAMED07611819473317 EUDAMED07611819473201 EUDAMED07611819473331 EUDAMED07611819473294 EUDAMED07611819473010 EUDAMED07611819473478 EUDAMED07611819503779 EUDAMED07611819503724 EUDAMED07611819473584 EUDAMED07611819473560 EUDAMED07611819473409 EUDAMED07611819503731 EUDAMED07611819473263 EUDAMED07611819473355 EUDAMED07611819473225 EUDAMED07611819473621 EUDAMED07611819503700 EUDAMED07611819473249 EUDAMED07611819473386 EUDAMED
- Basic UDI-DI
- 7611819a00516JQ EUDAMED
- Direct Marketing DI
- 07611819473447 EUDAMED07611819473034 EUDAMED07611819473072 EUDAMED07611819473539 EUDAMED07611819473317 EUDAMED07611819473201 EUDAMED07611819473331 EUDAMED07611819473294 EUDAMED07611819473010 EUDAMED07611819473478 EUDAMED07611819503779 EUDAMED07611819503724 EUDAMED07611819473584 EUDAMED07611819473560 EUDAMED07611819473409 EUDAMED07611819503731 EUDAMED07611819473263 EUDAMED07611819473355 EUDAMED07611819473225 EUDAMED07611819473621 EUDAMED07611819503700 EUDAMED07611819473249 EUDAMED07611819473386 EUDAMED
- EMDN Code
- Z12139099 VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
Category: Orthopaedic guidewire, reusable
Acis by Synthes GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 7611819a00516JQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Synthes GmbH
- EUDAMED SRN
- CH-MF-000013345
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (23)
- EUDAMED 72d192f9-2453-4288-a37f-58a1e8553f71 61 fields · synced Sep 17, 2026
- EUDAMED de436751-2288-4425-9a3a-cedc171fc4f2 61 fields · synced May 16, 2026
- EUDAMED a5fb291f-b240-46b5-a899-ab6fe05f6a5b 61 fields · synced May 16, 2026
- EUDAMED 55386f67-0533-46ad-8480-ff9a7695dcc3 61 fields · synced May 16, 2026
- EUDAMED 60dd6421-cfa1-4fde-b256-b06e11b96ba8 61 fields · synced May 17, 2026
- EUDAMED ec1ef137-1ae2-44d2-a6b4-5623ca281d9a 61 fields · synced May 17, 2026
- EUDAMED a93552db-6353-46cf-ad25-6d30a68c5c52 61 fields · synced May 17, 2026
- EUDAMED 1d0cf2c0-7bac-4b33-8145-c9a69be79ef4 61 fields · synced May 17, 2026
- EUDAMED 4a45b394-3331-49ca-b489-00ac4083a145 61 fields · synced May 17, 2026
- EUDAMED 7a292af7-dfb4-4f08-9f8e-97eca914a970 61 fields · synced May 17, 2026
- EUDAMED f2f39511-43c8-45fc-8b5b-183a0cbbee58 61 fields · synced May 17, 2026
- EUDAMED b35270c0-12c7-4485-93de-ac0d8c97ab63 61 fields · synced May 17, 2026
- EUDAMED 677f723e-3054-456a-83b3-a88f25561879 61 fields · synced May 17, 2026
- EUDAMED 42fcd32b-07a0-4396-b914-6e516e48b971 61 fields · synced May 17, 2026
- EUDAMED 32366a6d-4146-46d0-a867-7cfe222466af 61 fields · synced May 17, 2026
- EUDAMED 780cac82-17f8-4cbf-b778-153538c8be78 61 fields · synced May 18, 2026
- EUDAMED 27382fa1-4654-4a28-ac25-8c687c751dff 61 fields · synced May 18, 2026
- EUDAMED 0ebced23-1c5a-4576-b868-e1548e663680 61 fields · synced May 18, 2026
- EUDAMED 21c5f3b7-4a09-4013-bc73-1796d360413e 61 fields · synced May 18, 2026
- EUDAMED b4d145ad-3067-423e-a0ae-bae6c9afb82c 61 fields · synced May 18, 2026
- EUDAMED 50823cf3-3c5e-420e-8c8d-9ea2c10b374a 61 fields · synced May 18, 2026
- EUDAMED c2f41ab6-2447-4452-9658-cd239ca1af52 61 fields · synced May 19, 2026
- EUDAMED 9f62bf07-e4e5-474d-82c9-3682af284186 61 fields · synced May 19, 2026