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Opescope Acteno
EUDAMEDClass IIb (EU MDR)
Ref 566-24400-34Model SURGICAL MOBILE C-ARM IMAGING SYSTEM OPESCOPE ACTENO
Identity
- Trade Name
- OPESCOPE ACTENO EUDAMEDSURGICAL MOBILE C-ARM IMAGING SYSTEM OPESCOPE ACTENO EUDAMED
- Device Name
- SURGICAL MOBILE C-ARM IMAGING SYSTEM OPESCOPE ACTENO EUDAMED
- Model / Reference
- 566-24400-34 EUDAMEDSURGICAL MOBILE C-ARM IMAGING SYSTEM OPESCOPE ACTENO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04540217065202 EUDAMED
- Basic UDI-DI
- B-04540217065202 EUDAMED45402170100000000000015SX EUDAMED
- EMDN Code
- Z11030780 REMOTE CONTROL TABLES - HARDWARE ACCESSORIES 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
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
Opescope Acteno by Shimadzu Corporation — Class IIb — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04540217065202 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-04540217065202 | 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 (2)
- EUDAMED 8295b07a-d751-4ee0-95a6-68a91a6af769 61 fields · synced Jul 13, 2026
- EUDAMED 4f8b9061-3932-440a-9370-582fcfe8f25e 61 fields · synced May 19, 2026