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Bone Screws
EUDAMEDClass IIb (EU MDR)
Ref 42519028EModel 4.0mm Low profile cancellous screw, self-tappping, partial threads, Hex (titianium alloy),φ4.0×28
Identity
- Trade Name
- Bone Screws EUDAMED
- Device Name
- 4.0mm Low profile cancellous screw, self-tappping, partial threads, Hex (titianium alloy),φ4.0×28 EUDAMED
- Model / Reference
- 4.0mm Low profile cancellous screw, self-tappping, partial threads, Hex (titianium alloy),φ4.0×28 EUDAMED42519028E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931720478098 EUDAMED
- Basic UDI-DI
- B-06931720478098 EUDAMED
- EMDN Code
- P09120602 CANCELLOUS SCREWS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bone Screws by Stryker Trauson (Changzhou) Medical Technology 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-06931720478098 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000005689
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 91d796ec-8416-44b4-a6c2-2efae18939b2 61 fields · synced Sep 30, 2026