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3.2mm Cutter
EUDAMEDClass IIa (EU MDR)
Ref BA-31900-000Model CUVIS-joint Cutter
by Curexo, Inc.
Identity
- Trade Name
- 3.2mm Cutter EUDAMED
- Device Name
- Surgical Invasive Instruments for CUVIS-joint / Cutter EUDAMED
- Model / Reference
- CUVIS-joint Cutter EUDAMEDBA-31900-000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800043850073 EUDAMED
- Basic UDI-DI
- 88000438CJBUU EUDAMED
- EMDN Code
- Z12130485 STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
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
3.2mm Cutter by CUREXO, Inc. — Class IIa — 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 | 88000438CJBUU | Class IIa | Active |
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Manufacturer
- Manufacturer
- Curexo, Inc.
- EUDAMED SRN
- KR-MF-000014563
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 15ad46e8-9f4f-4bb1-96b0-ef8dcf1f8501 61 fields · synced Jun 14, 2026