Identity
- Device Name
- 4.8mm Locking Screw EUDAMED
- Model / Reference
- T40254875 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06943139641536 EUDAMED
- Basic UDI-DI
- B-06943139641536 EUDAMED
- EMDN Code
- P09120201 INTRAMEDULLARY NAILS 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: Arthrodesis intramedullary nail, non-distracting
4.8mm Locking Screw by Tianjin Zhengtian Medical Instrument Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Arthrodesis intramedullary nail, non-distracting.
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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-06943139641536 | 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 edea3be1-c542-4c22-baaf-6c17df9c977d 61 fields · synced Oct 6, 2026