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HemoScreen Blood Dispensing Cup
EUDAMEDFDA UDIClass A (EU MDR)
Ref AC-MA-00100Model HemoScreen200
Identity
- Trade Name
- HemoScreen Blood Dispensing Cup EUDAMEDHemoCup FDA UDI
- Generic Name
- Blood/blood culture specimen transfer spike IVD, manual FDA UDI
- Device Name
- HemoScreen EUDAMEDA disposable unit used for dispensing blood from a test tube. FDA UDI
- Model / Reference
- HemoScreen200 EUDAMEDAC-MA-00100 EUDAMEDHemoCup FDA UDI
- Description
- A disposable unit used for dispensing blood from a test tube. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290016991062 EUDAMEDFDA UDI
- Basic UDI-DI
- 7290016991HS200Accessor7G EUDAMED
- FDA Product Code
- LXG FDA UDI
- EMDN Code
- W0501010180 VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Blood/blood culture specimen transfer spike IVD, manual FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2050 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
HemoScreen Blood Dispensing Cup by Pixcell Medical Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 7290016991HS200Accessor7G | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Pixcell Medical Ltd.
- EUDAMED SRN
- IL-MF-000026612
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED e4dad829-0c29-4659-8ecc-06e0a5a5f0e9 61 fields · synced Jun 18, 2026
- FDA UDI 6789013f-3d97-4c98-ab4d-3e5fb800a068 33 fields · synced May 30, 2026