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Autologous Platelet Separator Disposables Kit
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref MDK300
Identity
- Trade Name
- Autologous Platelet Separator Disposables Kit EUDAMEDFDA UDI
- Generic Name
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
- Device Name
- Magellan® Autologous Platelet Separator Disposables Kit EUDAMEDSterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument. FDA UDI
- Model / Reference
- MDK300 EUDAMEDFDA UDI
- Description
- Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument. FDA UDI
Identifiers
- Catalog Number
- MDK300 FDA UDI
- Primary DI / UDI-DI
- +M896MDK3000 EUDAMEDM896MDK3000 FDA UDI
- Basic UDI-DI
- ++M896MDK3007J EUDAMED
- EMDN Code
- B019003 BLOOD COMPONENTS ALIQUOTATION KITS EUDAMED
- GMDN Term
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Autologous Platelet Separator Disposables Kit by Arteriocyte Medical Systems, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | ++M896MDK3007J | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Arteriocyte Medical Systems, Inc
- EUDAMED SRN
- US-MF-000011472
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 4ec2e785-f886-4932-8701-3d57f2cc0280 61 fields · synced Jul 22, 2026
- FDA UDI 446b648e-4353-42ea-b3e5-c53d2462d448 35 fields · synced May 30, 2026