Identity
- Trade Name
- FiXcision EUDAMED
- Device Name
- FiXcision EUDAMED
- Model / Reference
- FIX2001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EAMIFIX20011 EUDAMED
- Basic UDI-DI
- ++EAMIA43B4C1D2LM EUDAMED
- Unit of Use DI
- +EAMIFIX20010 EUDAMED
- EMDN Code
- V0199 CUTTING DEVICES, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
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
Category: Cranial bur, single-use
FiXcision by A.m.i. Agency For Medical Innovations Gmbh — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Cranial bur, single-use.
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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 | ++EAMIA43B4C1D2LM | Class IIa | Active |
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Manufacturer
- Manufacturer
- A.M.I. Agency for Medical Innovations GmbH
- EUDAMED SRN
- AT-MF-000016792
Sources (1)
- EUDAMED 0c85fb5b-5954-4151-b9fe-35293883a4ac 61 fields · synced Jul 16, 2026