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GSS 5.5 Rod
EUDAMEDClass IIb (EU MDR)
Ref F15AB-PA00343Ref F15AB-PA00106Ref F15AB-PA00339Ref F15AB-PA00465Ref F15AB-PA00347Ref F15AB-PA00101Ref F15AB-PA00341Ref F15AB-PA00100Ref F15AB-PA00345Ref F15AB-PA00103Ref F15AB-PA00346Ref F15AB-PA00076Ref F15AB-PA00464
Identity
- Trade Name
- GSS 5.5 Rod EUDAMEDRod EUDAMED
- Device Name
- Non-sterile Spinal Internal Fixation Systems EUDAMED
- Model / Reference
- F15AB-PA00343 EUDAMEDF15AB-PA00106 EUDAMEDF15AB-PA00339 EUDAMEDF15AB-PA00465 EUDAMEDF15AB-PA00347 EUDAMEDF15AB-PA00101 EUDAMEDF15AB-PA00341 EUDAMEDF15AB-PA00100 EUDAMEDF15AB-PA00345 EUDAMEDF15AB-PA00103 EUDAMEDF15AB-PA00346 EUDAMEDF15AB-PA00076 EUDAMEDF15AB-PA00464 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512062579 EUDAMED06942512062487 EUDAMED06942512062500 EUDAMED06942512062548 EUDAMED06942512062616 EUDAMED06942512062432 EUDAMED06942512062524 EUDAMED06942512062425 EUDAMED06942512062593 EUDAMED06942512062456 EUDAMED06942512062609 EUDAMED06943242385310 EUDAMED06942512062531 EUDAMED
- Basic UDI-DI
- B-06942512062579 EUDAMEDB-06942512062487 EUDAMEDB-06942512062500 EUDAMEDB-06942512062548 EUDAMEDB-06942512062616 EUDAMEDB-06942512062432 EUDAMEDB-06942512062524 EUDAMEDB-06942512062425 EUDAMEDB-06942512062593 EUDAMEDB-06942512062456 EUDAMEDB-06942512062609 EUDAMEDB-06943242385310 EUDAMEDB-06942512062531 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
GSS 5.5 Rod 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-06942512062579 | 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 (13)
- EUDAMED b1a89865-388c-4884-a2ed-b156de4c7bcd 61 fields · synced Aug 2, 2026
- EUDAMED b579aafc-a7b5-4428-b052-3f2da628160b 61 fields · synced May 17, 2026
- EUDAMED 14f4cac3-1c48-4edd-963a-07d82ce8a080 61 fields · synced May 17, 2026
- EUDAMED ca937be1-85b6-4e32-a08a-e381d312c25a 61 fields · synced May 18, 2026
- EUDAMED aa44d4fd-9ba1-4364-8498-56130eb4d59d 61 fields · synced May 18, 2026
- EUDAMED 2f27485c-77c6-4e83-a0a1-c44e242da448 61 fields · synced May 18, 2026
- EUDAMED b41d34f5-77dd-4598-8687-8646f4e3f3fe 61 fields · synced May 18, 2026
- EUDAMED 78b08607-b534-49d6-890e-974b93cc932c 61 fields · synced May 18, 2026
- EUDAMED e648ee4e-4306-40f7-8d32-f1221624efce 61 fields · synced May 18, 2026
- EUDAMED 9e59b347-fa51-446c-b419-3359cabb5f75 61 fields · synced May 18, 2026
- EUDAMED 55a3f26d-652f-4852-af26-9b9806396820 61 fields · synced May 19, 2026
- EUDAMED b50eaed4-2bcb-4eb8-a204-d1c83b5d3bea 61 fields · synced May 19, 2026
- EUDAMED 0e0c71c7-ec54-46e0-b02d-508b20178feb 61 fields · synced May 19, 2026