Identity
- Device Name
- Favored Angle Pedicle Screw (OCT) EUDAMED
- Model / Reference
- T03143528 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921814202623 EUDAMED
- Basic UDI-DI
- B-06921814202623 EUDAMED
- EMDN Code
- P09070301 CERVICAL FIXATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Portugal 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: Cervical spine immobilization system, single-use
Favored Angle Pedicle Screw (OCT) by Tianjin Zhengtian Medical Instrument Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Cervical spine immobilization system, single-use.
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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-06921814202623 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Tianjin Zhengtian Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000020115
- Authorised Representative
- Inion Oy FI-AR-000046224
Sources (1)
- EUDAMED 5cba6443-500c-4e83-bfc0-ace50c4cd59f 61 fields · synced Jun 19, 2026