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Fili Con Oliva Ø2mm L400mm Hap St 2pz
EUDAMEDClass IIb (EU MDR)
Ref 5000343HST2Model Filo
by Mikai s.p.a.
Identity
- Trade Name
- FILI CON OLIVA Ø2MM L400MM HAP ST 2PZ EUDAMED
- Device Name
- Acciaio HAP EUDAMED
- Model / Reference
- Filo EUDAMED5000343HST2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056630553500 EUDAMED
- Basic UDI-DI
- 805573143IMP00HAPWIRE.S9T 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 Con Oliva Ø2mm L400mm Hap St 2pz by Mikai s.p.a. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 (1)
- EUDAMED 22b21e25-7eff-479f-9a03-0e28a5673d4f 61 fields · synced Aug 4, 2026