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multiSTATION® RIGID miniARM®
EUDAMEDFDA UDIClass I (EU MDR)
Ref 080950Model 080900
Identity
- Trade Name
- multiSTATION® RIGID miniARM® EUDAMEDminiARM® multiSTATION™ System FDA UDI
- Generic Name
- Surgical instrument assist arm system structural component FDA UDI
- Device Name
- multiSTATION® SubX™ STERNAL ASCENDER™ SYSTEM EUDAMEDM55™ RIGID miniARM® HOLDER FDA UDI
- Model / Reference
- 080900 EUDAMED080950 EUDAMEDFDA UDI
- Description
- M55™ RIGID miniARM® HOLDER FDA UDI
Identifiers
- Catalog Number
- 080950 FDA UDI
- Primary DI / UDI-DI
- 00850012846147 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850200006miniARM82 EUDAMED
- Direct Marketing DI
- 00850012846147 EUDAMED
- FDA Product Code
- MDM FDA UDI
- EMDN Code
- L0318 INSTRUMENTS FOR SUPPORT OF SURGICAL DEVICES, REUSABLE EUDAMED
- GMDN Term
- Surgical instrument assist arm system structural component FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
multiSTATION® RIGID miniARM® by LSI Solutions, Inc. — 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 | 0850200006miniARM82 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- LSI SOLUTIONS, Inc.
- EUDAMED SRN
- US-MF-000008267
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED d597597c-77eb-431b-9f8c-a131a7635f59 61 fields · synced Jul 11, 2026
- FDA UDI c3e5a950-a050-4dd5-9b61-4c4ac3018789 36 fields · synced May 30, 2026