Identity
- Trade Name
- HemoFlow 500 Basic EUDAMEDHemoFlow FDA UDI
- Generic Name
- Blood donation rocker FDA UDI
- Device Name
- HemoFlow 500 Basic EUDAMEDHemoFlow 500 Basic/Blood Donation Rocker FDA UDI
- Model / Reference
- 905000001 EUDAMED9-0500-0001 FDA UDI
- Description
- HemoFlow 500 Basic/Blood Donation Rocker FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850047037084 EUDAMEDFDA UDI
- Basic UDI-DI
- 08500470379050000012V EUDAMED
- Direct Marketing DI
- 00850047037084 EUDAMED
- FDA Product Code
- KSQ FDA UDI
- EMDN Code
- W02070103,W02070404 EUDAMED
- GMDN Term
- Blood donation rocker FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 864.9195 FDA UDI
- Market of Registration
- Northern Ireland 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
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
HemoFlow 500 Basic by Applied Science, 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 | 08500470379050000012V | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Applied Science, Inc.
- EUDAMED SRN
- US-MF-000040843
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 9c87c821-5869-4613-88df-d9b152cf22d1 61 fields · synced Jun 19, 2026
- FDA UDI 15f871ee-8a44-4060-9ac0-a1d029018988 34 fields · synced May 27, 2026