Identity
- Device Name
- NexSys PCS EUDAMED
- Model / Reference
- PCS-300-INT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 30812747011741 EUDAMED
- Basic UDI-DI
- 081274701PLS0013J EUDAMED
- EMDN Code
- Z12170401 BLOOD DONATION APHERESIS EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
NexSys PCS by Haemonetics Corporation — 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 | 081274701PLS0013J | Class IIb | Active |
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Manufacturer
- Manufacturer
- Haemonetics Corporation
- EUDAMED SRN
- US-MF-000034539
- Authorised Representative
- Haemonetics Italia s.r.l IT-AR-000021067
Sources (1)
- EUDAMED c7fa5adf-086e-43d6-8611-68ad3c16daef 61 fields · synced Jun 18, 2026