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Accuryn Monitor Floor Stand
EUDAMEDFDA UDIClass I (EU MDR)
Ref FGN-06-100195Model FGN-06-102112
Identity
- Trade Name
- Accuryn Monitor Floor Stand EUDAMEDFDA UDI
- Generic Name
- Transportable medical equipment stand, non-powered FDA UDI
- Device Name
- Accuryn Monitor High Mount EUDAMEDThe Accuryn Monitor Floor Stand is used to hold the Accuryn Monitor on the floor near the patient’s bed during stationary use. The Floor Stand is offered in tall and short heights. FDA UDI
- Model / Reference
- FGN-06-102112 EUDAMEDFGN-06-100195 EUDAMEDFDA UDI
- Description
- The Accuryn Monitor Floor Stand is used to hold the Accuryn Monitor on the floor near the patient’s bed during stationary use. The Floor Stand is offered in tall and short heights. FDA UDI
Identifiers
- Catalog Number
- FGN-06-100195 FDA UDI
- Primary DI / UDI-DI
- 00850019755220 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850019755MountStand9C EUDAMED
- Direct Marketing DI
- 00850019755220 EUDAMED
- FDA Product Code
- EZL FDA UDIPHU FDA UDIEXY FDA UDI
- EMDN Code
- U99 DEVICES FOR UROGENITAL SYSTEM - OTHER EUDAMED
- GMDN Term
- Transportable medical equipment stand, non-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5130 FDA UDI876.1800 FDA UDI
- Market of Registration
- Belgium 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Accuryn Monitor Floor Stand by Potrero Medical, 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 | 0850019755MountStand9C | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Potrero Medical, Inc.
- EUDAMED SRN
- US-MF-000033318
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 6697ec5e-e181-482f-8c5a-c6da107d209f 61 fields · synced Oct 6, 2026
- FDA UDI dcace2f1-fd56-4622-bf33-1b6666beab99 35 fields · synced May 30, 2026