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Rondella Per Vite Con Testa Ø4.0mm Øesterno 7.5mm St
EUDAMEDClass IIb (EU MDR)
Ref BTR40007WSTModel Rondella
by Mikai s.p.a.
Identity
- Trade Name
- RONDELLA PER VITE CON TESTA Ø4.0MM ØESTERNO 7.5MM ST EUDAMED
- Device Name
- BSS EUDAMED
- Model / Reference
- Rondella EUDAMEDBTR40007WST EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055400678825 EUDAMED
- Basic UDI-DI
- 805573143BSS00000WASHERYT EUDAMED
- EMDN Code
- P091280 OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES 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
Rondella Per Vite Con Testa Ø4.0mm Øesterno 7.5mm St by Mikai s.p.a. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 805573143BSS00000WASHERYT | Class IIb | Active |
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Manufacturer
- Manufacturer
- Mikai s.p.a.
- EUDAMED SRN
- IT-MF-000030732
Sources (1)
- EUDAMED 66faf567-0706-41a9-ba47-fbb6fbb2ad78 61 fields · synced Jul 15, 2026