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Fili Lisci Ø1.8mm L400mm Hap St
EUDAMEDClass IIb (EU MDR)
Ref 5000340HSTModel FiloRef 5000340ST
by Mikai s.p.a.
Identity
- Trade Name
- FILI LISCI Ø1.8MM L400MM HAP ST EUDAMEDFILI LISCI Ø1.8MM L400MM ST EUDAMED
- Device Name
- Acciaio HAP EUDAMEDAcciaio EUDAMED
- Model / Reference
- Filo EUDAMED5000340HST EUDAMED5000340ST EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056630553227 EUDAMED08055731430802 EUDAMED
- Basic UDI-DI
- 805573143IMP00HAPWIRE.S9T EUDAMED805573143IMP00000WIRE.SX5 EUDAMED
- EMDN Code
- P09120301 KIRSCHNER BONE WIRES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
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
Category: Orthopaedic bone pin, non-bioabsorbable
Fili Lisci Ø1.8mm L400mm Hap St by Mikai s.p.a. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthopaedic bone pin, non-bioabsorbable.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 805573143IMP00HAPWIRE.S9T | Class IIb | Active |
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Manufacturer
- Manufacturer
- Mikai s.p.a.
- EUDAMED SRN
- IT-MF-000030732
Sources (2)
- EUDAMED a2a0cfb0-7caa-4176-a41a-4703c75fdf0f 61 fields · synced Aug 2, 2026
- EUDAMED c6597614-2d5a-485f-b546-42a49c21407a 61 fields · synced Jul 15, 2026