5' Radiolucent Imaging Top (350 Lbs)
by Mizuho Orthopedic Systems, Inc.
Ref 5806
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0842430158956Y 00842430114182 | Date2 May 2022 | StatusActive |
| United States | GUDID listing GUDID | Number00842430114182 | Date30 Jul 2021 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Universal operating table top
- Device Name
- Operating Table Accessories
- Model / Ref / Catalog
- 5806
- Primary DI / UDI-DI
- 00842430114182
- Basic UDI-DI
- 0842430158956Y
- Direct Marketing DI
- 00842430114182
- FDA Product Code
- JEA
- EMDN Code
- Z12011280 Patient positioning instruments - hardware accessories
- GMDN Term
- Universal operating table top
- Device Class
- Class I
- Regulation Number
- 878.4960
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Manufacturer details
- EUDAMED SRN
- US-MF-000002901
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Mizuho Orthopedic Systems, Inc.
Properties
Other properties (21)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Lot / Batch Number: No
- Expiration Date: No