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Automatic Cell Separation System
EUDAMEDFDA UDIClass A (EU MDR)
Ref -Model Auto-Pure 2400
Identity
- Trade Name
- Automatic Cell Separation System EUDAMEDALLSHENG FDA UDI
- Generic Name
- Magnetic particle separation instrument IVD FDA UDI
- Device Name
- Automatic Cell Separation System EUDAMED
- Model / Reference
- Auto-Pure 2400 EUDAMEDFDA UDI- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975141982055 EUDAMEDFDA UDI
- Basic UDI-DI
- 697514198AS215F9 EUDAMED
- FDA Product Code
- JJH FDA UDI
- EMDN Code
- W0299 IVD INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Magnetic particle separation instrument IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2310 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
Yes
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
No
FDA UDI
Automatic Cell Separation System by Hangzhou Allsheng Instruments Co., Ltd — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 697514198AS215F9 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Hangzhou Allsheng Instruments Co., Ltd
- EUDAMED SRN
- CN-MF-000020502
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED bfea3874-5571-4830-8207-ef438c0a8229 61 fields · synced Jun 19, 2026
- FDA UDI c93fe00b-9f94-4dc6-85c4-033e759064f0 32 fields · synced May 30, 2026