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Monoaxial Reduction Screw(Dual)
EUDAMEDClass IIb (EU MDR)
Ref F15AB-PA00595Ref F15AB-PA00600Ref F15AB-PA00598Ref F15AB-PA00609Ref F15AB-PA00616Ref F15AB-PA00597Ref F15AB-PA00619Ref F15AB-PA00608Ref F15AB-PA00613Ref F15AB-PA00607Ref F15AB-PA00623Ref F15AB-PA00620Ref F15AB-PA00618Ref F15AB-PA00606Ref F15AB-PA00601
Identity
- Trade Name
- Monoaxial Reduction Screw(Dual) EUDAMED
- Device Name
- Non-sterile Spinal Internal Fixation Systems EUDAMED
- Model / Reference
- F15AB-PA00595 EUDAMEDF15AB-PA00600 EUDAMEDF15AB-PA00598 EUDAMEDF15AB-PA00609 EUDAMEDF15AB-PA00616 EUDAMEDF15AB-PA00597 EUDAMEDF15AB-PA00619 EUDAMEDF15AB-PA00608 EUDAMEDF15AB-PA00613 EUDAMEDF15AB-PA00607 EUDAMEDF15AB-PA00623 EUDAMEDF15AB-PA00620 EUDAMEDF15AB-PA00618 EUDAMEDF15AB-PA00606 EUDAMEDF15AB-PA00601 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512060520 EUDAMED06942512060605 EUDAMED06942512060551 EUDAMED06942512060759 EUDAMED06942512060865 EUDAMED06942512060544 EUDAMED06942512060933 EUDAMED06942512060704 EUDAMED06942512060797 EUDAMED06942512060698 EUDAMED06942512060971 EUDAMED06942512060940 EUDAMED06942512060889 EUDAMED06942512060681 EUDAMED06942512060612 EUDAMED
- Basic UDI-DI
- B-06942512060520 EUDAMEDB-06942512060605 EUDAMEDB-06942512060551 EUDAMEDB-06942512060759 EUDAMEDB-06942512060865 EUDAMEDB-06942512060544 EUDAMEDB-06942512060933 EUDAMEDB-06942512060704 EUDAMEDB-06942512060797 EUDAMEDB-06942512060698 EUDAMEDB-06942512060971 EUDAMEDB-06942512060940 EUDAMEDB-06942512060889 EUDAMEDB-06942512060681 EUDAMEDB-06942512060612 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 Reduction 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-06942512060520 | 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 efb4406c-bfc1-4f62-9b69-202a817e8ca8 61 fields · synced Jul 27, 2026
- EUDAMED c6188ae7-b7b8-417a-8bcb-5c7b75129b46 61 fields · synced May 16, 2026
- EUDAMED 8f257b70-38c8-4e22-aea2-ff8f4660d0a8 61 fields · synced May 16, 2026
- EUDAMED 6c6f2a2e-86ea-49c0-85ee-e2a16d4548fa 61 fields · synced May 17, 2026
- EUDAMED 97caebc4-f527-47a7-82e9-88bfe7f21bd3 61 fields · synced May 17, 2026
- EUDAMED ccfb4a7d-f388-4fe9-8b37-efcdef8a8fc5 61 fields · synced May 17, 2026
- EUDAMED 895fcb2f-7c4c-4c98-85ee-c1bf11c2578a 61 fields · synced May 17, 2026
- EUDAMED 03fc638d-50fb-44ad-855c-72972591e82f 61 fields · synced May 17, 2026
- EUDAMED 22ca62b2-cb3b-44a8-a4f2-2b3eb530d733 61 fields · synced May 17, 2026
- EUDAMED cdde9f5f-8d29-4f41-a614-859ba9fbce38 61 fields · synced May 17, 2026
- EUDAMED 2d49429f-3117-49a8-b1ce-0b0de65c94ae 61 fields · synced May 17, 2026
- EUDAMED 854e5ca8-309f-4af4-87ac-d8e16661926f 61 fields · synced May 18, 2026
- EUDAMED b4faf7b4-1875-406f-8925-cf849f4fdf13 61 fields · synced May 18, 2026
- EUDAMED 26338b9f-97be-4eb6-9471-712f203785aa 61 fields · synced May 19, 2026
- EUDAMED b87cf13f-ab74-4489-82a4-cce65e7418db 61 fields · synced May 19, 2026