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Autologous Platelet Separator System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BTI200
Identity
- Trade Name
- Autologous Platelet Separator System EUDAMEDAutologous Platelet Separator FDA UDI
- Generic Name
- Haematological concentrate system centrifuge FDA UDI
- Device Name
- Magellan® Autologous Platelet Separator EUDAMEDMAGELLAN® Autologous Platelet Separator System consists of the Platelet Separator Instrument and the associated Platelet Rich Plasma Sterile Disposable Kits. FDA UDI
- Model / Reference
- BTI200 EUDAMEDFDA UDI
- Description
- MAGELLAN® Autologous Platelet Separator System consists of the Platelet Separator Instrument and the associated Platelet Rich Plasma Sterile Disposable Kits. FDA UDI
Identifiers
- Catalog Number
- BTI200 FDA UDI
- Primary DI / UDI-DI
- +M896BTI2000 EUDAMEDM896BTI2000 FDA UDI
- Basic UDI-DI
- ++M896BTI2007Y EUDAMED
- FDA Product Code
- JQC FDA UDI
- EMDN Code
- B0501 PLATELET GEL AUTOMATIC PREPARATION DEVICES (EXCLUDING BAGS) EUDAMED
- GMDN Term
- Haematological concentrate system centrifuge FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2050 FDA UDI
- Market of Registration
- Spain 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Autologous Platelet Separator System 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 | ++M896BTI2007Y | 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 f31e9f53-522f-4771-b556-d96f02de63a2 61 fields · synced Jul 12, 2026
- FDA UDI ccf80c3b-16f3-4e50-8dd8-00ef9210bd63 35 fields · synced May 30, 2026