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Accuryn Monitor High Mount
EUDAMEDFDA UDIClass I (EU MDR)
Ref FGN-06-102111Model FGN-06-102112
Identity
- Trade Name
- Accuryn Monitor High Mount EUDAMEDFDA UDI
- Generic Name
- Portable active medical device mount FDA UDI
- Device Name
- Accuryn Monitor High Mount EUDAMEDThe Accuryn Monitor High Mount is used to hold Accuryn Monitor near the patient’s bed during stationary use or transport. The Monitor High Mount can also be placed on top of the Floor Stand to raise the drainage bag up to drain the bag more easily. This monitor mount consists of one molded piece. FDA UDI
- Model / Reference
- FGN-06-102112 EUDAMEDFDA UDIFGN-06-102111 EUDAMED
- Description
- The Accuryn Monitor High Mount is used to hold Accuryn Monitor near the patient’s bed during stationary use or transport. The Monitor High Mount can also be placed on top of the Floor Stand to raise the drainage bag up to drain the bag more easily. This monitor mount consists of one molded piece. FDA UDI
Identifiers
- Catalog Number
- FGN-06-102112 FDA UDI
- Primary DI / UDI-DI
- 00850019755244 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850019755MountStand9C EUDAMED
- Direct Marketing DI
- 00850019755244 EUDAMED
- FDA Product Code
- EZL FDA UDIPHU FDA UDIEXY FDA UDI
- EMDN Code
- U99 DEVICES FOR UROGENITAL SYSTEM - OTHER EUDAMED
- GMDN Term
- Portable active medical device mount 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 High Mount 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 35bd7b25-d992-428d-9db0-d51372db5554 61 fields · synced Jun 18, 2026
- FDA UDI 2fc99694-7fd1-4d8b-8cce-72151f35036f 35 fields · synced May 30, 2026