Identity
- Trade Name
- FLEXAVISION EUDAMED
- Device Name
- REMOTE-CONTROLLED R/F SYSTEM FLEXAVISION EUDAMED
- Model / Reference
- 566-28000-06 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04540217068081 EUDAMED
- Basic UDI-DI
- B-04540217068081 EUDAMED
- EMDN Code
- Z11030701,Z11030702 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Flexavision by Shimadzu Corporation — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04540217068081 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shimadzu Corporation
- EUDAMED SRN
- JP-MF-000025145
- Authorised Representative
- Shimadzu Europa GmbH DE-AR-000013563
Sources (1)
- EUDAMED 1ababbaf-e5e4-44e8-b433-688356ed886e 61 fields · synced Jun 18, 2026