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Polyaxial Reduction Screw (Dual)
EUDAMEDClass IIb (EU MDR)
Ref F15AB-PA00552Ref F15AB-PA00556Ref F15AB-PA00539Ref F15AB-PA00541Ref F15AB-PA00563Ref F15AB-PA00544Ref F15AB-PA00551Ref F15AB-PA00542Ref F15AB-PA00559Ref F15AB-PA00553Ref F15AB-PA00561Ref F15AB-PA00543Ref F15AB-PA00540Ref F15AB-PA00558Ref F15AB-PA00537
Identity
- Trade Name
- Polyaxial Reduction Screw (Dual) EUDAMED
- Device Name
- Non-sterile Spinal Internal Fixation Systems EUDAMED
- Model / Reference
- F15AB-PA00552 EUDAMEDF15AB-PA00556 EUDAMEDF15AB-PA00539 EUDAMEDF15AB-PA00541 EUDAMEDF15AB-PA00563 EUDAMEDF15AB-PA00544 EUDAMEDF15AB-PA00551 EUDAMEDF15AB-PA00542 EUDAMEDF15AB-PA00559 EUDAMEDF15AB-PA00553 EUDAMEDF15AB-PA00561 EUDAMEDF15AB-PA00543 EUDAMEDF15AB-PA00540 EUDAMEDF15AB-PA00558 EUDAMEDF15AB-PA00537 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512062067 EUDAMED06942512062142 EUDAMED06942512061848 EUDAMED06942512061893 EUDAMED06942512062258 EUDAMED06942512061923 EUDAMED06942512062050 EUDAMED06942512061909 EUDAMED06942512062173 EUDAMED06942512062074 EUDAMED06942512062234 EUDAMED06942512061916 EUDAMED06942512061855 EUDAMED06942512062166 EUDAMED06942512061824 EUDAMED
- Basic UDI-DI
- B-06942512062067 EUDAMEDB-06942512062142 EUDAMEDB-06942512061848 EUDAMEDB-06942512061893 EUDAMEDB-06942512062258 EUDAMEDB-06942512061923 EUDAMEDB-06942512062050 EUDAMEDB-06942512061909 EUDAMEDB-06942512062173 EUDAMEDB-06942512062074 EUDAMEDB-06942512062234 EUDAMEDB-06942512061916 EUDAMEDB-06942512061855 EUDAMEDB-06942512062166 EUDAMEDB-06942512061824 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
Polyaxial Reduction Screw (Dual) by Wuhan Mindray Scientific Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-06942512062067 | 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 (15)
- EUDAMED 180754b1-e0e3-41e7-b2a7-61f7101b49d4 61 fields · synced Aug 1, 2026
- EUDAMED 0a671f2a-f7c3-47f3-a258-aa75c5e15151 61 fields · synced May 16, 2026
- EUDAMED 4b9582f8-c908-4763-8160-cabeb27470ca 61 fields · synced May 17, 2026
- EUDAMED 5bf34f82-8ccc-423d-8b21-edd9d2c78e45 61 fields · synced May 17, 2026
- EUDAMED f231f95f-8257-4197-a9da-5f9431be3467 61 fields · synced May 17, 2026
- EUDAMED a79cd5ce-3882-42c1-b084-e333f28d4813 61 fields · synced May 17, 2026
- EUDAMED aead690b-3ede-47fb-a6e7-ec03836a8d5e 61 fields · synced May 18, 2026
- EUDAMED 871dcf6c-be0e-4741-a0b4-fa5618eda88f 61 fields · synced May 18, 2026
- EUDAMED e7868159-bff8-4d25-9360-a744b2645227 61 fields · synced May 18, 2026
- EUDAMED 3fa58914-1faa-4757-a5e3-4f2483b96264 61 fields · synced May 18, 2026
- EUDAMED 98492a2e-30d5-424a-ba58-d2d1683927be 61 fields · synced May 18, 2026
- EUDAMED fceff9cf-eb01-4050-ae4c-77aaaa158172 61 fields · synced May 18, 2026
- EUDAMED 8901d764-45f2-4a9b-a500-3c8bf66da8b6 61 fields · synced May 19, 2026
- EUDAMED f365bdab-e735-4f97-92c5-3b81af88da7b 61 fields · synced May 19, 2026
- EUDAMED 85151716-daf9-4d97-b59c-9a39d488f35f 61 fields · synced May 19, 2026