Identity
- Trade Name
- Straight Ti Rod EUDAMED
- Device Name
- Occipital Cervical and Thoracic Posterior Posterior Fixation System EUDAMED
- Model / Reference
- ZJX-B1 EUDAMED19901644 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941641501676 EUDAMED
- Basic UDI-DI
- B-06941641501676 EUDAMED
- EMDN Code
- P09070301 CERVICAL FIXATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Czechia 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
Straight Ti Rod by Beijing Fule Science & Technology Development 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-06941641501676 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000006511
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 97b7127d-2d6f-462a-90bd-231957f7d340 61 fields · synced Jul 11, 2026