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Monoaxial Pedicle Screw (Dual)
EUDAMEDClass IIb (EU MDR)
Ref F15AB-PA00566Ref F15AB-PA00569Ref F15AB-PA00572Ref F15AB-PA00574Ref F15AB-PA00580Ref F15AB-PA00575Ref F15AB-PA00586Ref F15AB-PA00591Ref F15AB-PA00571Ref F15AB-PA00567Ref F15AB-PA00589Ref F15AB-PA00582Ref F15AB-PA00570Ref F15AB-PA00594Ref F15AB-PA00577Ref F15AB-PA00593Ref F15AB-PA00578
Identity
- Trade Name
- Monoaxial Pedicle Screw (Dual) EUDAMED
- Device Name
- Non-sterile Spinal Internal Fixation Systems EUDAMED
- Model / Reference
- F15AB-PA00566 EUDAMEDF15AB-PA00569 EUDAMEDF15AB-PA00572 EUDAMEDF15AB-PA00574 EUDAMEDF15AB-PA00580 EUDAMEDF15AB-PA00575 EUDAMEDF15AB-PA00586 EUDAMEDF15AB-PA00591 EUDAMEDF15AB-PA00571 EUDAMEDF15AB-PA00567 EUDAMEDF15AB-PA00589 EUDAMEDF15AB-PA00582 EUDAMEDF15AB-PA00570 EUDAMEDF15AB-PA00594 EUDAMEDF15AB-PA00577 EUDAMEDF15AB-PA00593 EUDAMEDF15AB-PA00578 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512059876 EUDAMED06942512059906 EUDAMED06942512059968 EUDAMED06942512059982 EUDAMED06942512060100 EUDAMED06942512060018 EUDAMED06942512060209 EUDAMED06942512060292 EUDAMED06942512059951 EUDAMED06942512059883 EUDAMED06942512060230 EUDAMED06942512060124 EUDAMED06942512059944 EUDAMED06942512060322 EUDAMED06942512060032 EUDAMED06942512060315 EUDAMED06942512060049 EUDAMED
- Basic UDI-DI
- B-06942512059876 EUDAMEDB-06942512059906 EUDAMEDB-06942512059968 EUDAMEDB-06942512059982 EUDAMEDB-06942512060100 EUDAMEDB-06942512060018 EUDAMEDB-06942512060209 EUDAMEDB-06942512060292 EUDAMEDB-06942512059951 EUDAMEDB-06942512059883 EUDAMEDB-06942512060230 EUDAMEDB-06942512060124 EUDAMEDB-06942512059944 EUDAMEDB-06942512060322 EUDAMEDB-06942512060032 EUDAMEDB-06942512060315 EUDAMEDB-06942512060049 EUDAMED
- EMDN Code
- P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Spinal bone screw, non-bioabsorbable
Monoaxial Pedicle Screw (Dual) by Wuhan Mindray Scientific Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Spinal bone screw, non-bioabsorbable.
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- AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
- Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06942512059876 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Wuhan Mindray Scientific Co., Ltd.
- EUDAMED SRN
- CN-MF-000032692
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (17)
- EUDAMED 45ca3086-c014-45a0-a807-b52df340dad8 61 fields · synced Sep 17, 2026
- EUDAMED f18ff80b-8f71-4efc-a1f3-d6e9644257a4 61 fields · synced May 16, 2026
- EUDAMED 84be3722-6d61-4259-ba77-25ff1511822a 61 fields · synced May 17, 2026
- EUDAMED c1f91113-2b48-4ce6-af45-be913268c76d 61 fields · synced May 17, 2026
- EUDAMED d0eb16cd-cb58-4217-9a50-5a8cc1ae4af7 61 fields · synced May 17, 2026
- EUDAMED fcb8d2ab-2a20-4741-a950-28f2ff438ff7 61 fields · synced May 17, 2026
- EUDAMED 85ac785e-b602-43c8-a595-2eb151fca5f6 61 fields · synced May 17, 2026
- EUDAMED 3d152d2b-6b63-4586-abe8-ed5dda535766 61 fields · synced May 17, 2026
- EUDAMED 4e1f17d0-cb9f-4986-bcb1-f43dfc02d452 61 fields · synced May 17, 2026
- EUDAMED 061429ed-9504-43f3-a570-e2f65ade657f 61 fields · synced May 17, 2026
- EUDAMED 691f1a35-9004-4d20-bd65-5e92c74f7f5d 61 fields · synced May 17, 2026
- EUDAMED c083f8ab-10cd-424b-bcc8-4b8a48c9c5e3 61 fields · synced May 18, 2026
- EUDAMED d2a8e070-d96b-4c9d-9044-a9201dbfe3c0 61 fields · synced May 18, 2026
- EUDAMED 08c03715-71c7-4cb4-aaa6-8797f3b7ac87 61 fields · synced May 18, 2026
- EUDAMED aab2c156-359b-4c53-8836-641948ca45ad 61 fields · synced May 19, 2026
- EUDAMED 67387628-5376-4055-a9db-179504346d54 61 fields · synced May 19, 2026
- EUDAMED 171064a8-9ca8-4c00-9586-0f3e5cac907c 61 fields · synced May 19, 2026