Mindray
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Mindray FDA UDI
- Generic Name
- Universal operating table, electrohydraulic FDA UDI
- Device Name
- Operating table EUDAMED
- Model / Reference
- HyBase V8 EUDAMEDHyBase V8 Classic EUDAMEDHyBase V6 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06948350517332 EUDAMEDFDA UDI
- Basic UDI-DI
- 69483505HyBase8300*****BA EUDAMED
- Direct Marketing DI
- 06948350517332 EUDAMED
- FDA Product Code
- FQO FDA UDI
- EMDN Code
- Z12011202 OPERATING TABLES EUDAMED
- GMDN Term
- Universal operating table, electrohydraulic FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4960 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
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
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Universal operating table, electrohydraulic
Mindray by Nanjing Mindray Bio-Medical Electronics Co., Ltd — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Nanjing Mindray Bio-Medical Electronics Co., Ltd
Sources (2)
- FDA UDI 6f0e136e-d1b4-487f-a338-0144762ce7eb 32 fields · synced Sep 18, 2026
- EUDAMED 4ca7c776-b085-4fe5-89f0-89e65499cfce 61 fields · synced Sep 18, 2026