Identity
- Trade Name
- IV pole EUDAMEDFDA UDI
- Generic Name
- Freestanding/bed-attached intravenous pole FDA UDI
- Device Name
- IV pole EUDAMEDElectrical Hospital Bed Accessory to be used for holding other medical devices such as infusion bag FDA UDI
- Model / Reference
- KC-56A EUDAMEDFDA UDI
- Description
- Electrical Hospital Bed Accessory to be used for holding other medical devices such as infusion bag FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04527799701476 EUDAMEDFDA UDI
- Basic UDI-DI
- 4527799TD73M27700FJ EUDAMED
- FDA Product Code
- FNL FDA UDI
- EMDN Code
- V080280,V08068099,Z12030399 EUDAMED
- GMDN Term
- Freestanding/bed-attached intravenous pole FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5100 FDA UDI
- 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
IV pole by Paramount Bed Co., Ltd. — 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 | 4527799TD73M27700FJ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Paramount Bed Co., Ltd.
- EUDAMED SRN
- JP-MF-000002285
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED fd60ef37-a8b0-4ff4-8131-2b3b08eb5246 61 fields · synced Jul 11, 2026
- FDA UDI 0da43679-d153-4b46-964a-8df2c196e6ff 33 fields · synced May 30, 2026