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Reamer
EUDAMEDClass I (EU MDR)
Ref 03.607.000Model USS Orthopaedic Prostheses Reamers and BursRef 03.628.106Model USS Fracture MIS Orthopaedic Prostheses Reamers and BursRef 03.607.100Ref 03.632.046Model Matrix Spine Orthopaedic Prostheses Reamers and BursRef 03.630.134Model FACET WEDGE Orthopaedic Prostheses Reamers and Burs
by Synthes GmbH
Identity
- Device Name
- Reamer EUDAMED
- Model / Reference
- USS Orthopaedic Prostheses Reamers and Burs EUDAMED03.607.000 EUDAMEDUSS Fracture MIS Orthopaedic Prostheses Reamers and Burs EUDAMED03.628.106 EUDAMED03.607.100 EUDAMEDMatrix Spine Orthopaedic Prostheses Reamers and Burs EUDAMED03.632.046 EUDAMEDFACET WEDGE Orthopaedic Prostheses Reamers and Burs EUDAMED03.630.134 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07611819185364 EUDAMED07611819475939 EUDAMED07611819423909 EUDAMED07611819379510 EUDAMED07611819587939 EUDAMED
- Basic UDI-DI
- 7611819a00215J7 EUDAMED7611819a00211HX EUDAMED7611819a00128JB EUDAMED7611819a00188JV EUDAMED
- Direct Marketing DI
- 07611819185364 EUDAMED07611819475939 EUDAMED07611819423909 EUDAMED07611819379510 EUDAMED07611819587939 EUDAMED
- EMDN Code
- L091102 ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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: Acetabular orthopaedic reamer
Reamer by Synthes GmbH — Class I — 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 | 7611819a00215J7 | Class I | Active |
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Manufacturer
- Manufacturer
- Synthes GmbH
- EUDAMED SRN
- CH-MF-000013345
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (5)
- EUDAMED 9376c235-42dc-4777-93e4-c644b73d4c9a 61 fields · synced Jul 24, 2026
- EUDAMED 6c9d8e33-a1dc-4689-946b-fd925a553def 61 fields · synced May 18, 2026
- EUDAMED 64c0e09a-ce6c-49df-b5c3-c009cedecfb2 61 fields · synced May 18, 2026
- EUDAMED 2c814587-94e0-42b5-825b-e5859d51ebc7 61 fields · synced May 19, 2026
- EUDAMED cd5d4fd1-07bb-47f2-a2fb-d06a4af005a9 61 fields · synced May 19, 2026