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1.2u161cs-31
EUDAMEDClass IIb (EU MDR)
Ref 582-24315-13Model X-ray tube assembly 1.2U161CS-31Ref 582-24315-03Ref 582-24315-02Ref 582-24315-12
Identity
- Trade Name
- 1.2U161CS-31 EUDAMED
- Device Name
- X-ray tube assembly 1.2U161CS-31 EUDAMED
- Model / Reference
- X-ray tube assembly 1.2U161CS-31 EUDAMED582-24315-13 EUDAMED582-24315-03 EUDAMED582-24315-02 EUDAMED582-24315-12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04540217069316 EUDAMED04540217063802 EUDAMED04540217051465 EUDAMED04540217069309 EUDAMED
- Basic UDI-DI
- B-04540217069316 EUDAMEDB-04540217063802 EUDAMEDB-04540217051465 EUDAMEDB-04540217069309 EUDAMED
- EMDN Code
- Z11039012 X-RAY TUBE ASSEMBLY 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
1.2u161cs-31 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-04540217069316 | 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 (4)
- EUDAMED 621b3b50-c6dc-480e-8813-8e1773d54755 61 fields · synced Jul 24, 2026
- EUDAMED 03e399d4-0ee0-42ea-94d9-9f34ffe77101 61 fields · synced May 18, 2026
- EUDAMED 3ae30699-0cd7-4b59-81e6-6cda95a6bc96 61 fields · synced May 18, 2026
- EUDAMED 2d1cf731-7131-4e54-a185-98263ec17074 61 fields · synced May 18, 2026