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Plt&Rbc Set W/Plt&Rbc Filter
EUDAMEDClass IIb (EU MDR)
Ref 949FF-EModel PLT&RBC Set w/PLT&RBC Filter
Identity
- Trade Name
- PLT&RBC SET W/PLT&RBC FILTER EUDAMED
- Model / Reference
- PLT&RBC Set w/PLT&RBC Filter EUDAMED949FF-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10812747012430 EUDAMED
- Basic UDI-DI
- 081274701MCS003X9 EUDAMED
- EMDN Code
- B030104 APHERESIS MULTIPLE BLOOD COMPONENT COLLECTION DEVICES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Plt&Rbc Set W/Plt&Rbc Filter by Haemonetics S.A. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081274701MCS003X9 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Haemonetics S.A.
- EUDAMED SRN
- CH-MF-000034549
- Authorised Representative
- Haemonetics Italia s.r.l IT-AR-000021067
Sources (1)
- EUDAMED 6f889f25-5012-4b56-8690-5a52abf91c99 61 fields · synced Jun 17, 2026