Identity
- Trade Name
- Promerix EUDAMEDFDA UDI
- Generic Name
- Universal operating table, electrohydraulic FDA UDI
- Device Name
- Operating Table / Active EUDAMEDOperating table FDA UDI
- Model / Reference
- 100060000 EUDAMEDPromerix FDA UDI
- Description
- Operating table FDA UDI
Identifiers
- Catalog Number
- 100060000 FDA UDI
- Primary DI / UDI-DI
- 06438435600009 EUDAMEDFDA UDI
- Basic UDI-DI
- 643843505RE EUDAMED
- Direct Marketing DI
- 06438435600009 EUDAMED
- FDA Product Code
- GDC 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
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Promerix by Merivaara Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 643843505RE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Merivaara Corporation
- EUDAMED SRN
- FI-MF-000001175
Sources (2)
- EUDAMED f774a3c0-efda-4e52-9ba0-b3df9597be6d 61 fields · synced Jun 18, 2026
- FDA UDI b33d15af-01f1-4772-babf-297ffe48fa54 36 fields · synced May 30, 2026