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Polyaxial Pedicle Screw(Dual)
EUDAMEDClass IIb (EU MDR)
Ref F15AB-PA00533Ref F15AB-PA00522Ref F15AB-PA00523Ref F15AB-PA00291Ref F15AB-PA00307Ref F15AB-PA00518Ref F15AB-PA00302Ref F15AB-PA00524Ref F15AB-PA00535Ref F15AB-PA00283Ref F15AB-PA00296Ref F15AB-PA00521Ref F15AB-PA00509Ref F15AB-PA00514Ref F15AB-PA00516Ref F15AB-PA00293Ref F15AB-PA00510Ref F15AB-PA00306Ref F15AB-PA00532Ref F15AB-PA00284Ref F15AB-PA00530Ref F15AB-PA00519Ref F15AB-PA00525Ref F15AB-PA00298Ref F15AB-PA00520Ref F15AB-PA00304Ref F15AB-PA00517Ref F15AB-PA00512Ref F15AB-PA00508
Identity
- Trade Name
- Polyaxial Pedicle Screw(Dual) EUDAMEDPolyaxial Pedicle Screw EUDAMED
- Device Name
- Non-sterile Spinal Internal Fixation Systems EUDAMED
- Model / Reference
- F15AB-PA00533 EUDAMEDF15AB-PA00522 EUDAMEDF15AB-PA00523 EUDAMEDF15AB-PA00291 EUDAMEDF15AB-PA00307 EUDAMEDF15AB-PA00518 EUDAMEDF15AB-PA00302 EUDAMEDF15AB-PA00524 EUDAMEDF15AB-PA00535 EUDAMEDF15AB-PA00283 EUDAMEDF15AB-PA00296 EUDAMEDF15AB-PA00521 EUDAMEDF15AB-PA00509 EUDAMEDF15AB-PA00514 EUDAMEDF15AB-PA00516 EUDAMEDF15AB-PA00293 EUDAMEDF15AB-PA00510 EUDAMEDF15AB-PA00306 EUDAMEDF15AB-PA00532 EUDAMEDF15AB-PA00284 EUDAMEDF15AB-PA00530 EUDAMEDF15AB-PA00519 EUDAMEDF15AB-PA00525 EUDAMEDF15AB-PA00298 EUDAMEDF15AB-PA00520 EUDAMEDF15AB-PA00304 EUDAMEDF15AB-PA00517 EUDAMEDF15AB-PA00512 EUDAMEDF15AB-PA00508 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512061596 EUDAMED06942512061404 EUDAMED06942512061411 EUDAMED06942512075708 EUDAMED06942512075982 EUDAMED06942512061329 EUDAMED06942512075890 EUDAMED06942512061428 EUDAMED06942512061619 EUDAMED06942512075609 EUDAMED06942512075791 EUDAMED06942512061350 EUDAMED06942512061183 EUDAMED06942512061268 EUDAMED06942512061282 EUDAMED06942512075760 EUDAMED06942512061190 EUDAMED06942512075975 EUDAMED06942512061589 EUDAMED06942512075616 EUDAMED06942512061527 EUDAMED06942512061336 EUDAMED06942512061435 EUDAMED06942512075852 EUDAMED06942512061343 EUDAMED06942512075951 EUDAMED06942512061312 EUDAMED06942512061244 EUDAMED06942512061176 EUDAMED
- Basic UDI-DI
- B-06942512061596 EUDAMEDB-06942512061404 EUDAMEDB-06942512061411 EUDAMEDB-06942512075708 EUDAMEDB-06942512075982 EUDAMEDB-06942512061329 EUDAMEDB-06942512075890 EUDAMEDB-06942512061428 EUDAMEDB-06942512061619 EUDAMEDB-06942512075609 EUDAMEDB-06942512075791 EUDAMEDB-06942512061350 EUDAMEDB-06942512061183 EUDAMEDB-06942512061268 EUDAMEDB-06942512061282 EUDAMEDB-06942512075760 EUDAMEDB-06942512061190 EUDAMEDB-06942512075975 EUDAMEDB-06942512061589 EUDAMEDB-06942512075616 EUDAMEDB-06942512061527 EUDAMEDB-06942512061336 EUDAMEDB-06942512061435 EUDAMEDB-06942512075852 EUDAMEDB-06942512061343 EUDAMEDB-06942512075951 EUDAMEDB-06942512061312 EUDAMEDB-06942512061244 EUDAMEDB-06942512061176 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
Polyaxial 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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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-06942512061596 | 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 (29)
- EUDAMED 83d4f365-87ff-4b33-8ca9-5171dbbd3a29 61 fields · synced Sep 30, 2026
- EUDAMED a7ea01c0-c9f1-459f-b422-7fbab3a81f2f 61 fields · synced May 16, 2026
- EUDAMED 8da8f355-1a10-46c7-b8aa-1683cfcbc8f6 61 fields · synced May 16, 2026
- EUDAMED 24448ddb-679f-47a8-9137-d0a221ab9a79 61 fields · synced May 16, 2026
- EUDAMED 85010fd0-886b-4d59-887c-2db327b30399 61 fields · synced May 16, 2026
- EUDAMED e4ef4441-75e8-4f60-b31b-8d159dc6bb29 61 fields · synced May 16, 2026
- EUDAMED 1ae10cd8-676a-423e-8bc0-8cd53c4ce152 61 fields · synced May 17, 2026
- EUDAMED 3bb866d8-923e-499e-85cd-312bbb2bb7f1 61 fields · synced May 17, 2026
- EUDAMED de5a414f-f7f3-4af8-85b5-ca8f0caeaf4e 61 fields · synced May 17, 2026
- EUDAMED a09476cb-5c6c-4e08-80ac-1c0a402f93ca 61 fields · synced May 17, 2026
- EUDAMED 50c48de9-a63e-42e8-906e-e7b0c7a768ae 61 fields · synced May 17, 2026
- EUDAMED e9828a47-2fe3-4b6c-a6a6-1a53253537db 61 fields · synced May 17, 2026
- EUDAMED 3b267ea5-3a61-4f25-9a23-aac37943a44c 61 fields · synced May 17, 2026
- EUDAMED 19ca18ed-04ba-4408-b929-7a25f097eb0c 61 fields · synced May 17, 2026
- EUDAMED 33f7c477-266a-492a-afa7-f0a3de13f141 61 fields · synced May 17, 2026
- EUDAMED 35dd2b1e-7866-4dba-9342-3addc3875209 61 fields · synced May 17, 2026
- EUDAMED 394bf15b-864a-4231-8ffd-17e31f40e1a4 61 fields · synced May 17, 2026
- EUDAMED 0edb9b99-914f-4c17-b9e1-d79772b2ce44 61 fields · synced May 18, 2026
- EUDAMED a1aed27d-720c-46fa-921c-626eb21fd404 61 fields · synced May 18, 2026
- EUDAMED e1882119-bb74-4bff-b646-247098696bc6 61 fields · synced May 18, 2026
- EUDAMED 39c271b8-1a8b-4a35-b208-b6074b88e281 61 fields · synced May 18, 2026
- EUDAMED cffff2a0-ab73-451d-9f2e-7de9a5116992 61 fields · synced May 18, 2026
- EUDAMED fc1f1a04-3824-4286-84f6-677ea12a3a38 61 fields · synced May 18, 2026
- EUDAMED cbdab5d1-9da4-4bf4-8765-a98023abead0 61 fields · synced May 18, 2026
- EUDAMED 2625127e-098c-488b-969d-15dbf78d6304 61 fields · synced May 18, 2026
- EUDAMED 1560ae8b-5ee3-4aa9-b86a-7177713da936 61 fields · synced May 18, 2026
- EUDAMED 7324ba7a-dcbc-4df0-9de8-e5754e40e3f6 61 fields · synced May 19, 2026
- EUDAMED 4e52d0d9-61af-4d5d-bf1b-6f18fd6907af 61 fields · synced May 19, 2026
- EUDAMED 7db1c0bf-5975-4900-a58c-0c6f0e38110a 61 fields · synced May 19, 2026